The FDA categorized the recall of more than 2.2 million Ellume Pty Ltd. COVID-19 Home Tests that began Oct. 5 as a class I recall, “the most serious type of recall.” While the agency has received significant criticism lately about ambiguity in recalls that often leaves consumers uncertain about their seriousness, the FDA eliminated all doubt on this one saying, “use of these tests may cause serious adverse health consequences or death.” The FDA said it received 35 reports of false positives associated with the antigen test. No deaths have been reported.

Johnson & Johnson (J&J) will spin off its consumer health division as a stand-alone public company, leaving J&J to focus on its pharmaceutical and medical device businesses.

Shares of cardiac diagnostics company Heartbeam Inc. (NASDAQ:BEAT) are trading lower than expected after it opened on the Nasdaq on Nov. 11. The digital health company priced its public offering of 2,750,000 units at $6, but as of midday, shares were trading at $4.56. It’s a disappointing start for the Santa Clara, Calif.-based company, which is developing an ECG telemedicine technology to diagnose cardiovascular patients for ambulatory settings.

The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.

Without a doubt, 2021 has been a strong year for med-tech M&As, which are valued at significantly more than each of the three prior years. The industry has completed 520 M&As worth $111.7 billion so far, which is 88% more than the next highest year, 2019’s $59.48 billion. The volume is 33% more than the 391 M&As completed in 2020. In addition to completed M&As, a total of 1,376 med-tech deals, including licensings, collaborations and joint ventures, have been completed. They are valued at $1.98 billion, with only 31 deals including financial terms. The number of med-tech deals this year are only slightly below the 1,400 completed by the end of the year in 2020.

U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20.