Intuitive Surgical Inc. benefited from keen interest in resuming surgeries during pandemic troughs and hospitals investing in its Da Vinci robotic system in preparation for a more endemic phase of COVID-19, Intuitive CEO Gary Guthart said in a presentation at the J.P. Morgan 40th Annual Healthcare Conference on Jan. 12. The company’s unaudited preliminary fourth quarter and full year 2021 results also showed strong growth in procedure volumes – 19% year-over-year compared to 2020 and 13% compared to 2019. Still, Intuitive reported that “during 2021, COVID-19 resurgences continued to impact Da Vinci procedure volumes. The impact of the COVID-19 pandemic on the company’s business has, and continues to, differ by geography and region.”
Robert Califf moved a step closer to his second stint as head of the U.S. FDA when the Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-8 Jan. 13 to favorably send his nomination to the full Senate for a confirmation vote.
In a speech on Jan. 13, President Joe Biden revealed plans to purchase an additional 500 million at-home COVID-19 tests, bringing the total number the administration expects to provide for free to American households to 1 billion. In addition, Biden said the administration would distribute free “high quality masks.” On Wednesday, the administration said it would provide 5 million rapid COVID-19 tests and 5 million lab-based PCR tests to schools each month to support screening testing and test-to-stay programs.
The existence of prior art isn’t always readily evident when companies in the device and diagnostic spaces file patent applications with the U.S. Patent and Trademark Office (PTO). As it turns out, literature describing that prior art need not be widely distributed to invalidate a patent as Quest Diagnostics Inc., of Secaucus, N.J., recently discovered, an object lesson for all in the med-tech space that research for prior art must be exhaustive if a patent is to hold up over time.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
Owens & Minor Inc. (O&M) sent Apria Inc. shares out of the ballpark with the announcement of its acquisition of the at-home health care company for $1.45 billion in cash early this morning. Apria’s stock (NASDAQ:APR) closed Friday at $29.72, opened today at $37.16 and rose incrementally throughout the day to close at $37.48. O&M’s stock (NYSE:OMI) ended the week at $45.08; it ebbed sharply to $40.19 on the news before recovering to $45.35 at the end of the trading day.
The FDA has posted a draft guidance responding to changes in the law regarding device shortages during public health emergencies. The guidance says that manufacturers should advise the FDA of any impending shortages, but the key qualifier, that of a “meaningful disruption” in production, may be sowing confusion in the industry.
Space travel has known effects on human health and biology. Some, such as loss of bone density, are well understood, while others, like inflammation, are not. Now, organ-on-a-chip maker Emulate Inc. is conducting experiments on the International Space Station U.S. National Laboratory (ISS-NL) aimed at revealing clues to how the brain functions in microgravity.
University of California San Diego engineers have developed tiny 2D sensors that pop up to become a 3D assemblage of microscopic sensors for directly measuring the movement and speed of electrical signals inside the heart. According to nanoengineering professor Sheng Xu, the nanotechnology has enormous implications for heart doctors anxious to better diagnose and treat arrhythmia, heart attack and other diseases.
RSS
