Danielle Kirsh

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.

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...

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).

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 breaks ground on $80M facility in Alabama Glaukos has begun construction on a new research, development, and manufacturing facility in Huntsville, Alabama.

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

A chart with maroon and gold horizontal bars showing that about half of Americans say it’s OK for journalists to advocate for communities, but there is less support for journalists expressing their political or religious views

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/...

BREAKING: US Supreme Court lets Trump cut diversity-related NIH grants reut.rs/3Jxk3Fr

And now the Supreme Court chimes in:

apnews.com/article/supr...

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.

The decision could result in the loss of National Institutes of Health grants worth hundreds of millions of dollars.

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.

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

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...