Medtech in a Minute: A Gut-Wrenching FDA Delay, and More

Catch up on the latest medtech news – in one minute or less.

Amanda Pedersen

January 20, 2023

2 Min Read
Medtech in a Minute graphic

Surmodics Takes a Regulatory Punch to the Gut

Surmodics has traveled a long road to bring its SurVeil drug-coated balloon (DCB) to the U.S. market, and that road just got considerably longer. The company received an FDA letter this week that its premarket approval (PMA) application is not currently approvable. The agency wants to see additional information regarding the biocompatibility of the device and the labeling, which would require additional testing and analysis. The silver lining is that the agency did not question the human clinical data submitted, nor did it ask for additional clinical data.

Medtech M&A Activity Picks Up

Shockwave, Baush + Lomb, and Bayer all announced acquisitions this week. Shockwave agreed to buy Neovasc for about $100 million plus up to $47 million in milestone payments tied to regulatory achievement. Baush + Lomb said an affiliate has acquired AcuFocus, a company that has developed small aperture intraocular technology to address the diverse unmet needs in eye care. Bayer announced the acquisition of Blackford Analysis, a global strategic imaging AI platform and solutions provider. Neither Baush + Lomb nor Bayer disclosed financial terms of their respective deals.

Layoffs Hit Medtech Hard

PAVmed and its subsidiaries joined the growing list of medtech companies that are slashing workforces in 2023. The company is cutting 20% of its workforces. The news follows on the heels of Verily cutting 15% from its payroll. Earlier this month, Motus GI axed 45% of its workforce and said it would explore financial alternatives.

And in case you missed our last Medtech in a Minute report...

Zimmer Biomet 'Embodies' the M&A Spirit

Zimmer Biomet is already flexing its M&A muscles in 2023 with a deal valued at $275 million. The company has agreed to pay $155 million at closing and up to an additional $120 million in milestone payments over a three-year period for a private company called Embody. The acquisition is expected to strengthen Zimmer Biomet's growing sports medicine portfolio and also supports the continued transformation of Zimmer Biomet.

Baxter Joins the Spinoff Revolution

Baxter International plans to spin off its renal care and acute therapies businesses into an independent, publicly traded company. This continues an industry trend from 2022 of large companies spinning off pieces in the name of portfolio management. Baxter's news coincides with the completion of GE Healthcare's spin from its previous parent company to become a standalone company in 2023.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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