Danielle Kirsh

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.

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Our guidelines for cancers like colon cancer are already outdated, resulting in thousands of 30+ year olds dying from cancer.

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.

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...

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.

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 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.

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

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.

Apple, Masimo spar over Apple Watch import ban at US appeals court reut.rs/3TrGNIJ

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...

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 applauds HHS, CMS efforts to improve prior authorizations AdvaMed voiced strong support this week for the Trump administration’s efforts to reform prior authorization.

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

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.

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...

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.

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.

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

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

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 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.

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

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.

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...

Senate confirms Dr. Martin Makary as FDA commissioner The new FDA commissioner, Makary has long advocated for disruptive technologies in the medical device industry.

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.

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.

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

Surgical Robotics Special Report From Asensus Surgical to Zimmer Biomet, discover information on 57 surgical robotics companies that have caught our attention at MassDevice.

The #SurgicalRobotics Special Report is finally here. I gathered data from 57 surgical robot companies, covering robots, applications, funding, revenue & more. Ranging from ortho robots to cardio robots, read more about these companies & their technology. The future of surgery is bright! #MedSky

I thought the same thing re: revenue. I don't think there was a skew. I gave companies the option to include funding stage and funds raised separately. Some companies chose not to include both, some chose to only include funding stage.

In a recent survey, I asked surgical robotics companies about their tech, funding stage, regulatory status & more. The full report will be out soon, but here’s a sneak peek at the financial disclosures we received.

What do you think these trends say about the future of surgical robotics? #Medtech

FDA cancels meeting to select flu strains for next season's shots The canceled meeting comes just days after a CDC vaccine advisory committee meeting was abruptly postponed.

NEWS: The FDA abruptly canceled its upcoming advisory committee meeting to select the strains for next year's flu shot.
by @berkeleyjr.bsky.social

Disability amid disaster: People with disabilities are disproportionately impacted by natural disasters After disasters, people with disabilities are more likely to be displaced, more likely to never return home and more likely to receive scam offers, Census Bureau data shows.

"The data also shows that once displaced, 21% of people with disabilities say they never return home, nearly four times the rate for those without disabilities." www.nbcnews.com/data-graphic...

Me, cooking something up for MassDevice and #medtech insiders for the last three weeks:

IYKYK! All I have to say is... the #surgicalrobotics industry is booming. I’ll be plating up bite-sized insights until the full project drops at the end of the month. Yes, chef!

University of Kentucky president just put out statement that Trump’s proposed NIH cuts “will cost UK tens of millions of dollars annually,” and hurt local economy and its work to advance health of the state — “including cancer, heart disease, children’s health, Alzheimer’s and opioid use disorder.”

This inventor laid the foundation for today's pacemakers Without African-American inventor and engineer Otis Boykin, pacemakers wouldn't have the pacing technology they do today.

Most people in #medtech know Earl Bakken, but few know about Otis Boykin—the Black engineer whose groundbreaking resistor technology made modern pacemakers possible. His tech paved the way for pacemakers that continue to evolve today. #MedSky

www.medicaldesignandoutsourcing.com/black-histor...

Federal health workers terrified after ‘DEI’ website publishes list of ‘targets’ The site calls out workers who have been involved with DEI initiatives. A majority are Black.

Scoop: Federal health workers are expressing fear and alarm after a website called “DEI Watch List” published the photos, names and public information of a number of workers across health agencies, describing them as “targets.” Reporting w/ Erika Edwards.

www.nbcnews.com/health/healt...

A sense of foreboding hangs over the National Institutes of Health There's widespread confusion and fear among scientists and doctors on the sprawling National Institutes of Health campus and at institutions dependent on the agency's funding.

There's widespread confusion and fear among scientists and doctors on the sprawling National Institutes of Health campus and at institutions dependent on the agency's funding.

Hi, I am @motherjones.com' disability reporter. In the following weeks, I am very interested in hearing how tariff nonsense impacts getting your meds and medical equipment. My email to get in touch is jmetraux@motherjones.com. Reposts appreciated.

Are you affected by the Trump administration’s pause on health communications, science meetings, and reviews? Have you been affected by the Trump administration’s pause on communications, science meetings, and reviews? @statnews would like to hear from you.

PLEASE REPOST: Health equity researchers, Please let me know if your centers or programs are being altered, closed, or threatened by your universities to comply with new EOs or if staff are being laid off. Signal: usha.22 or 👇(Won't use anything without permission.) www.statnews.com/2025/01/25/t...

Researchers reel as Trump administration moves quickly to cut funding and end DEI programs The rapidity with which the new administration is putting in place policies to end DEI programs is sowing fear among scientists

“We are going to go backward, and our health is going to decline,” said Derek Griffith.
Via @usha.bsky.social and Angus Chen at @statnews.com

www.statnews.com/2025/01/27/t...

Per an NIH source:

“Discussions with colleagues have suggested that if the universities all come together and raise hell about the delays to funding caused by not holding meetings, that might move the needle. From every state. There are well-funded universities in red states that will be impacted.”