Boston Scientific to Acquire Baylis Medical

Boston Scientific has signed an agreement to acquire Baylis Medical for an upfront payment of $1.75 billion. Boston Sci would gain Baylis's NRG and VersaCross Transseptal Platforms as well as a family of guidewires, sheaths, and dilators used to support left heart access. The deal would boost Boston Sci’s “efforts to improve procedural efficiencies with physician tools designed to make left atrial access safer and more predictable, with a focus on patient outcomes," said Mike Mahoney, chairman and CEO, Boston Scientific.

NIH Director Francis Collins to Step Down by End of 2021

Francis Collins has led the National Institutes of Health during the historic COVID-19 pandemic, during which the NIH received almost $4.9 billion to date to fund important COVID-19 research on diagnostic tests, vaccines, and treatments, according to the agency’s website. And during his 12-year stint he established initiatives to tackle some of the most pressing health issues. Collins plans to return to his lab at the National Human Genome Research Institute to study the causes and means of prevention for type 2 diabetes.

Acon Laboratories’s EUA Just in Time for Great Testing Push

Acon Laboratories has earned FDA emergency use authorization for its over-the-counter Flowflex COVID-19 Antigen Home Test. The nasal swab test may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old. The EUA comes just as FDA’s Director Jeff Shuren shared that FDA believes “at-home diagnostic tests play a critical role in the fight against COVID-19. We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.” FDA has now authorized more than 400 COVID-19 tests and sample collection devices since March of 2020. And, during an Oct. 6 press conference, the Biden administration said the federal government is investing an additional $1 billion to further mobilize testing manufacturers and keep up with the increased demand for COVID-19-related diagnostics.

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

Illumina Is in Boiling-Hot Water with the European Commission

Talk about seller's remorse. Illumina spun out Grail in 2016, but last year the commpany declared its intentions to buy it back. Antitrust regulators in the United States and Europe scruitinized the deal, but Illumina thumbed its nose at them, saying it would complete the acquisition anyway, but keep the companies separate until FTC in the United States wrapped up its investigation. Now, both companies are facing hefty fines from the European Commission, which said that this is the first time two companies have openly implemented their deal during an open antitrust investigation, blatently ignoring the standstill obligation.

Making Heads or Tails of the Latest Essure Data

FDA released updated adverse report data on what is probably the most controversial birth control device ever sold. The agency has received close to 64,000 reports related to Essure, but it's difficult to know how many of those reports are duplicates of previously-submitted information. FDA has also received 86 reports claiming to link the device to a death (not counting the eight that appeared to be incorrectly coded as death reports), but the information submitted on those deaths are spotty, making it tough to determine if the deaths were truly caused by the birth control implant.

First Major New CT Technology in Nearly a Decade

Siemens scored high praise from FDA this week after the agency cleared a device that uses the emerging CT imaging technology of photon-counting detectors, which can measure each individual X-ray that passes through a patient's body. Current systems use detectors that measure the total energy contained in many X-rays at once. By counting each individual X-ray photon, more detailed information about the patient can be obtained and used to create images with less information that is not useful in the review and analysis.

All of the medtech stories above appeared in the Qmed and MD+DI Daily newsletter. Click here to subscribe.