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. Read More
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. Read More
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. Read More
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. Read More
Mega Genomics Ltd. raised HK$153.4 million (US$20 million) in an initial public offering on the Stock Exchange of Hong Kong. Its shares jumped 16.7% in the middle of the first trading day on June 22 and closed at HK$18 a share. Beijing-based Mega Genomics plans to allocate 30% of the proceeds to the sales, marketing, and commercialization of its consumer genetic testing and cancer screening services and products. Read More
The U.S. FDA posted an updated safety communication regarding pulse oximetry accuracy with an eye toward those with darker skin pigmentation, a problem that has surfaced in the medical literature. The FDA said it intends to convene an advisory committee hearing later this year, suggesting that more strict performance standards for pulse oximeters are on the way. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical. Read More
