Danielle Kirsh
@medtechkirsh.bsky.social
award-winning #medtech journalist, transitioning to corporate media relations
also an advocate for equitable access to healthcare | open to corporate comms work: linktr.ee/daniellekirsh
~ 𝘰𝘱𝘪𝘯𝘪𝘰𝘯𝘴 𝘢𝘳𝘦 𝘮𝘺 𝘰𝘸𝘯 𝘢𝘯𝘥 𝘥𝘰𝘯’𝘵 𝘳𝘦𝘧𝘭𝘦𝘤𝘵 𝘮𝘺 𝘦𝘮𝘱𝘭𝘰𝘺𝘦𝘳 𝘢𝘯𝘥 𝘢𝘧𝘧𝘪𝘭𝘪𝘢𝘵𝘦𝘴 ~
also an advocate for equitable access to healthcare | open to corporate comms work: linktr.ee/daniellekirsh
~ 𝘰𝘱𝘪𝘯𝘪𝘰𝘯𝘴 𝘢𝘳𝘦 𝘮𝘺 𝘰𝘸𝘯 𝘢𝘯𝘥 𝘥𝘰𝘯’𝘵 𝘳𝘦𝘧𝘭𝘦𝘤𝘵 𝘮𝘺 𝘦𝘮𝘱𝘭𝘰𝘺𝘦𝘳 𝘢𝘯𝘥 𝘢𝘧𝘧𝘪𝘭𝘪𝘢𝘵𝘦𝘴 ~
Pinned
Danielle Kirsh
@medtechkirsh.bsky.social
· Nov 17
Hello BlueSky! 👋 Ready to dive into the fascinating world of #medtech?
I’m an award-winning journalist with MassDevice.com. I’m here to bring you breaking news, insights, and stories on the innovations shaping the future of healthcare. Let’s explore the future of healthcare together—follow along!
I’m an award-winning journalist with MassDevice.com. I’m here to bring you breaking news, insights, and stories on the innovations shaping the future of healthcare. Let’s explore the future of healthcare together—follow along!
New medical device submissions that require user fee payments will not be accepted during the Trump administration's government shutdown. The pause is expected to affect device makers preparing to file new 510(k), de novo or PMA submissions.
www.medicaldesignandoutsourcing.com/fda-halts-ne...
www.medicaldesignandoutsourcing.com/fda-halts-ne...
FDA halts new device submissions during government shutdown
The FDA will not accept new medical device submissions that require payment of user fees during the Trump administration's government shutdown.
www.medicaldesignandoutsourcing.com
October 2, 2025 at 3:32 PM
New medical device submissions that require user fee payments will not be accepted during the Trump administration's government shutdown. The pause is expected to affect device makers preparing to file new 510(k), de novo or PMA submissions.
www.medicaldesignandoutsourcing.com/fda-halts-ne...
www.medicaldesignandoutsourcing.com/fda-halts-ne...
CorWave has reported encouraging results for its Left Ventricular Assisting System (LVAS), designed to restore natural pulsatility in advanced heart failure patients. Findings suggest the device can be implanted safely & may address key complications seen with current continuous-flow LVADs. #Medtech
CorWave reports first patient results with membrane-based LVAS
CorWave presented positive interim results from its first-in-human study of the CorWave Left Ventricular Assisting System (LVAS).
www.massdevice.com
September 29, 2025 at 6:29 PM
CorWave has reported encouraging results for its Left Ventricular Assisting System (LVAS), designed to restore natural pulsatility in advanced heart failure patients. Findings suggest the device can be implanted safely & may address key complications seen with current continuous-flow LVADs. #Medtech
Glaukos is expanding its U.S. footprint with a major new facility in Alabama. The project marks a long-term investment in American #medtech manufacturing as the Trump administration questions the national security risk of medical device imports. www.medicaldesignandoutsourcing.com/glaukos-brea...
Glaukos breaks ground on $80M facility in Alabama
Glaukos has begun construction on a new research, development, and manufacturing facility in Huntsville, Alabama.
www.medicaldesignandoutsourcing.com
September 29, 2025 at 1:33 PM
Glaukos is expanding its U.S. footprint with a major new facility in Alabama. The project marks a long-term investment in American #medtech manufacturing as the Trump administration questions the national security risk of medical device imports. www.medicaldesignandoutsourcing.com/glaukos-brea...
Fellow #academics of Bluesky, how are you being taught to utilize artificial intelligence in your post-graduate work? I'm curious as a master's student (graduating in December 🎉) studying strategic communication. #academia #AI
September 22, 2025 at 5:04 PM
Fellow #academics of Bluesky, how are you being taught to utilize artificial intelligence in your post-graduate work? I'm curious as a master's student (graduating in December 🎉) studying strategic communication. #academia #AI
Reposted by Danielle Kirsh
Americans are split over whether it’s acceptable for journalists to advocate for the communities they cover, but more than half agree that journalists publicly expressing their political or religious views in their reporting is unacceptable. www.pewresearch.org/...
August 21, 2025 at 8:00 PM
Americans are split over whether it’s acceptable for journalists to advocate for the communities they cover, but more than half agree that journalists publicly expressing their political or religious views in their reporting is unacceptable. www.pewresearch.org/...
Reposted by Danielle Kirsh
BREAKING: US Supreme Court lets Trump cut diversity-related NIH grants reut.rs/3Jxk3Fr
August 21, 2025 at 8:58 PM
BREAKING: US Supreme Court lets Trump cut diversity-related NIH grants reut.rs/3Jxk3Fr
Reposted by Danielle Kirsh
August 21, 2025 at 9:13 PM
Reposted by Danielle Kirsh
The decision could result in the loss of National Institutes of Health grants worth hundreds of millions of dollars.
Supreme Court Allows Trump To Cut Millions In DEI-Related Health Grants
The decision could result in the loss of National Institutes of Health grants worth hundreds of millions of dollars.
www.forbes.com
August 21, 2025 at 9:35 PM
The decision could result in the loss of National Institutes of Health grants worth hundreds of millions of dollars.
FDA Commissioner Marty Makary says the nationwide shortage of common IV saline is officially over. The agency credits expanded manufacturing capacity and the use of temporary imports to stabilize supply. #MedTech #Pharma
FDA declares end to IV saline solutions shortage, but others persist
The FDA this week announced that the sodium chloride 0.9% injection product shortages have officially ended.
www.medicaldesignandoutsourcing.com
August 12, 2025 at 5:21 PM
Reposted by Danielle Kirsh
US FDA declines to approve Regeneron's blood cancer therapy for second time reut.rs/4fdFZRG
US FDA declines to approve Regeneron's blood cancer therapy for second time
Regeneron said on Friday the U.S. Food and Drug Administration has once again declined to approve its blood cancer therapy, this time in relation to observations from the regulator's inspection at a third-party manufacturing site.
reut.rs
August 1, 2025 at 2:25 PM
US FDA declines to approve Regeneron's blood cancer therapy for second time reut.rs/4fdFZRG
I’m younger than the breast cancer screening guidelines so copays for breast health appointments are always a $1200 “copay”. This is going to be awful for healthcare.
Our guidelines for cancers like colon cancer are already outdated, resulting in thousands of 30+ year olds dying from cancer.
Our guidelines for cancers like colon cancer are already outdated, resulting in thousands of 30+ year olds dying from cancer.
New exclusive 🗞️
Health secretary RFK Jr. plans to oust the members of an advisory panel that recommends which cancer screenings, HIV drugs and other preventive services insurers must cover at no cost
www.wsj.com/health/healt...
Health secretary RFK Jr. plans to oust the members of an advisory panel that recommends which cancer screenings, HIV drugs and other preventive services insurers must cover at no cost
www.wsj.com/health/healt...
Exclusive | RFK Jr. to Oust Advisory Panel on Cancer Screenings, HIV Prevention Drugs
The task force determines which preventive services insurers must cover at no cost to patients.
www.wsj.com
July 25, 2025 at 9:28 PM
I’m younger than the breast cancer screening guidelines so copays for breast health appointments are always a $1200 “copay”. This is going to be awful for healthcare.
Our guidelines for cancers like colon cancer are already outdated, resulting in thousands of 30+ year olds dying from cancer.
Our guidelines for cancers like colon cancer are already outdated, resulting in thousands of 30+ year olds dying from cancer.
Reposted by Danielle Kirsh
The FDA named George Tidmarsh, a longtime biotech executive who has a background in oncology and pediatrics, as its top drug regulator. www.statnews.com/2025/07/21/g...
FDA taps biotech veteran George Tidmarsh to lead drug center
The FDA named George Tidmarsh, who has led a number of biotech companies, to be its top drug regulator.
www.statnews.com
July 21, 2025 at 1:50 PM
The FDA named George Tidmarsh, a longtime biotech executive who has a background in oncology and pediatrics, as its top drug regulator. www.statnews.com/2025/07/21/g...
Substantial M&A news this morning: ZimVie has agreed to be acquired by an ARCHIMED affiliate for $730 million. ZimVie started as a spine and dental spinoff of Zimmer Biomet in 2022 and later sold its spine business in April 2024. #Medtech www.massdevice.com/zimvie-to-be...
ZimVie to be acquired by Archimed in $730M deal
ZimVie has agreed to be acquired by an affiliate of the healthcare investment firm Archimed for $19 a share in cash.
www.massdevice.com
July 21, 2025 at 1:35 PM
Substantial M&A news this morning: ZimVie has agreed to be acquired by an ARCHIMED affiliate for $730 million. ZimVie started as a spine and dental spinoff of Zimmer Biomet in 2022 and later sold its spine business in April 2024. #Medtech www.massdevice.com/zimvie-to-be...
Advamed President and CEO Scott Whitaker praised the Trump Administration’s “Big Beautiful Bill” passed by Congress last week. Whitaker called the bill’s tax provisions a boost for U.S. medical device research and manufacturing. #MedTech
AdvaMed applauds passage of 'Big Beautiful Bill'
Advamed President and CEO Scott Whitaker praised the Trump Administration's "Big Beautiful Bill" passed by Congress last week.
www.medicaldesignandoutsourcing.com
July 7, 2025 at 5:40 PM
Advamed President and CEO Scott Whitaker praised the Trump Administration’s “Big Beautiful Bill” passed by Congress last week. Whitaker called the bill’s tax provisions a boost for U.S. medical device research and manufacturing. #MedTech
Reposted by Danielle Kirsh
Apple, Masimo spar over Apple Watch import ban at US appeals court reut.rs/3TrGNIJ
Apple, Masimo spar over Apple Watch import ban at US appeals court
Apple asked a U.S. appeals court on Monday to overturn a trade tribunal's decision which forced it to remove blood-oxygen reading technology from its Apple Watches, in order to avoid a ban on its U.S. smartwatch imports.
reut.rs
July 7, 2025 at 5:25 PM
Apple, Masimo spar over Apple Watch import ban at US appeals court reut.rs/3TrGNIJ
A study about the disparities in organ allocations found that physicians were less likely to accept a donor liver or lung on behalf of Black transplant candidates. The researchers say the data doesn't necessarily point to clinician bias, but could offer new insights for clinical decision-making.
MIT and Mass General Hospital researchers find disparities in organ allocation
Analyzing organ transplant data from over 160,000 transplant candidates, MIT and Mass General Brigham researchers found a link between race and the likelihood of some organ procurement organizations a...
news.mit.edu
July 7, 2025 at 1:33 PM
A study about the disparities in organ allocations found that physicians were less likely to accept a donor liver or lung on behalf of Black transplant candidates. The researchers say the data doesn't necessarily point to clinician bias, but could offer new insights for clinical decision-making.
AdvaMed voiced strong support this week for the Trump administration’s efforts to reform prior authorization, following a pledge by major health insurers to improve the process across Medicare Advantage, Medicaid managed care, commercial plans, and the ACA marketplaces. #MedTech
AdvaMed applauds HHS, CMS efforts to improve prior authorizations
AdvaMed voiced strong support this week for the Trump administration’s efforts to reform prior authorization.
www.medicaldesignandoutsourcing.com
June 26, 2025 at 6:17 PM
AdvaMed voiced strong support this week for the Trump administration’s efforts to reform prior authorization, following a pledge by major health insurers to improve the process across Medicare Advantage, Medicaid managed care, commercial plans, and the ACA marketplaces. #MedTech
Interesting #medtech board move: Medtronic has appointed Emory Healthcare CEO Dr. Joon Lee to its board as an independent director. He will serve on the Science and Technology Committee and Compensation and Talent Committee of the Board.
www.massdevice.com/medtronic-ad...
www.massdevice.com/medtronic-ad...
Medtronic adds Emory Healthcare CEO to its board
Medtronic this week announced it appointed Emory Healthcare CEO Dr. Joon Lee to its board as an independent director, effective immediately.
www.massdevice.com
June 26, 2025 at 3:58 PM
Interesting #medtech board move: Medtronic has appointed Emory Healthcare CEO Dr. Joon Lee to its board as an independent director. He will serve on the Science and Technology Committee and Compensation and Talent Committee of the Board.
www.massdevice.com/medtronic-ad...
www.massdevice.com/medtronic-ad...
Providing a sneak peek into a quick write up I'm doing to ask if anyone else is being gaslit by Grammarly lately. I'm not a mathematician (I did have to Google to confirm I was right), but these volumes are very different.
June 17, 2025 at 4:07 PM
Providing a sneak peek into a quick write up I'm doing to ask if anyone else is being gaslit by Grammarly lately. I'm not a mathematician (I did have to Google to confirm I was right), but these volumes are very different.
Camille Chang Gilmore is leaving Boston Scientific after 20+ years leading HR and DEI. She’ll step into a new CHRO role in Atlanta mid-June. Read more about her departure and reflections on her time at BSC.
#Medtech
#Medtech
Boston Scientific’s longtime DEI, HR leader exits for chief HR role at new company
Camille Chang Gilmore, Boston Scientific’s global chief DEI officer announced she is leaving the company after two decades of service.
www.massdevice.com
May 30, 2025 at 8:16 PM
Camille Chang Gilmore is leaving Boston Scientific after 20+ years leading HR and DEI. She’ll step into a new CHRO role in Atlanta mid-June. Read more about her departure and reflections on her time at BSC.
#Medtech
#Medtech
Women's Health Access Matters (WHAM), a nonprofit focused on closing the gender gap in research and funding, just launched an investor network supporting early-stage women’s health startups. The initiative aims to turn overlooked ideas into breakthrough solutions. #Medtech
New investor network aims to boost early-stage women’s health innovation
WHAM has launched the Innovator's Circle, a new investor network designed to catalyze early-stage funding for women's health companies
www.medicaldesignandoutsourcing.com
May 28, 2025 at 7:09 PM
Women's Health Access Matters (WHAM), a nonprofit focused on closing the gender gap in research and funding, just launched an investor network supporting early-stage women’s health startups. The initiative aims to turn overlooked ideas into breakthrough solutions. #Medtech
Boston Scientific is officially discontinuing global sales of its Acurate TAVR devices, citing “prohibitive” regulatory hurdles following recent discussions with U.S. and EU authorities. The decision comes days after trial results raised questions about Acurate’s competitiveness. #Medtech
Boston Scientific discontinues Acurate TAVR sales, cites regulatory burden
Boston Scientific has discontinued global sales of its Acurate neo2 and Acurate Prime transcatheter aortic valve replacement (TAVR) systems.
www.massdevice.com
May 28, 2025 at 2:50 PM
Boston Scientific is officially discontinuing global sales of its Acurate TAVR devices, citing “prohibitive” regulatory hurdles following recent discussions with U.S. and EU authorities. The decision comes days after trial results raised questions about Acurate’s competitiveness. #Medtech
Big news in #medtech leadership this morning as former J&J MedTech EVP Ashley McEvoy takes over as CEO and President of Insulet Corp. www.drugdeliverybusiness.com/ashley-mcevo...
Ashley McEvoy named president and CEO at Insulet
Insulet (Nasdaq:PODD) announced today that its board of directors appointed Ashley McEvoy as president and CEO, effective immediately.
www.drugdeliverybusiness.com
April 28, 2025 at 2:54 PM
Big news in #medtech leadership this morning as former J&J MedTech EVP Ashley McEvoy takes over as CEO and President of Insulet Corp. www.drugdeliverybusiness.com/ashley-mcevo...
The U.S. Senate has voted 56-44 to confirm Dr. Martin Makary as FDA commissioner. During his confirmation hearing, Makary noted that he wants to advocate for more independent scientific review to create more localized treatments and alluded to putting more #medtech in the hands of consumers.
Senate confirms Dr. Martin Makary as FDA commissioner
The new FDA commissioner, Makary has long advocated for disruptive technologies in the medical device industry.
www.massdevice.com
March 26, 2025 at 5:49 PM
The U.S. Senate has voted 56-44 to confirm Dr. Martin Makary as FDA commissioner. During his confirmation hearing, Makary noted that he wants to advocate for more independent scientific review to create more localized treatments and alluded to putting more #medtech in the hands of consumers.
The latest this week is former Masimo CEO and founder Joe Kiani wants the court to toss an "empty voting" lawsuit. The lawsuit, filed by Masimo, alleges that Kiani collaborated with investment firm RTW Investments to manipulate Masimo’s 2024 annual shareholder meeting to retain control. #medtech
Former Masimo CEO Kiani wants court to toss 'empty voting' lawsuit
Former Masimo CEO Joe Kiani has petitioned a U.S. District Court to dismiss a lawsuit accusing him of orchestrating an "empty voting" scheme.
www.massdevice.com
March 11, 2025 at 4:22 PM
The latest this week is former Masimo CEO and founder Joe Kiani wants the court to toss an "empty voting" lawsuit. The lawsuit, filed by Masimo, alleges that Kiani collaborated with investment firm RTW Investments to manipulate Masimo’s 2024 annual shareholder meeting to retain control. #medtech