In an era of ever-increasing change in regulation of medical devices, the 2021 draft regulatory proposal by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) might have seemed like an invitation to regulatory balkanization. However, MHRA said the responses to the draft proposal indicated widespread support for “international collaboration with like-minded regulators,” thus reassuring industry that their developmental devices won’t face an entirely new set of barriers to access to a market of more than 67 million.
Sounds like Eargo Inc. received good news as Patient Square Capital signed a definitive agreement to purchase $100 million in senior secured convertible notes plus an additional $25 million in future investment subject to certain conditions. The new funds provide some breathing room for the hearing aid company, which has been rocked by a $34.37 million settlement with the Department of Justice (DOJ), questions about its ability to remain on the Nasdaq exchange following delayed filings of its 2021 annual report and first quarter 2022 report and a 97% drop in its stock price since its high in February 2021.
Analysts have warned that the medical device industry is not completely immune from any effects of a potential recession. With fears that a recession is looming, investment firm Needham said companies with capital equipment exposure could be the most vulnerable as hospitals look to repair equipment, instead of replacing it. During the 2008-2009 recession, sales in capital equipment declined for about 12 months, while procedure growth slowed for several years.
Megarobo Technologies Ltd. raised $300 million in its series C round financing to develop intelligence and automation solutions for life science companies. The financing was led by Goldman Sachs Asset Management LP, Asia Investment Capital Ltd., and GGV Capital.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical.
Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter.
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