For brain surgeons, the shift is the sticking point. When a surgeon opens the cranium to remove a tumor, the brain moves as much as 1 cm, making much of the pre-operative mapping of the tumor essentially useless. While the bulk of a lesion can be identified by its density, the tendrils blend into the surrounding tissue – and taking excess margins means more brain damage. Designs for Vision Inc.’s bright idea, a headlamp that illuminates a fluorescing tumor with a laser light, makes brain surgery quicker, safer and more accurate.

Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.

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.

General Electric Co. reported that it was dividing the company into three “well capitalized investment-grade companies with seasoned leadership teams.” The division of the huge conglomerate will start with the tax-free spin-off of GE Healthcare Ltd. in early 2023 and the renewable energy and power business in 2024 leaving the legacy GE as an aviation-focused enterprise. The company will take a one-time hit of $2 billion in connection with the split up.

Color Health Inc. followed its rainbow to another pot of gold, collecting $100 million in a series E financing round led by Kindred Ventures and funds advised by T. Rowe Price Associates Inc. Returning funding round participants also included General Catalyst, the company’s long-time lead investor, Viking Global Investors and Emerson Collective. With the latest cash infusion, the company’s total funds raised to date reached $378 million and its valuation of $4.6 billion propelled it into the top dozen health care unicorns. Founded in 2017 as Color Genomics, the Burlingame, Calif.-based company has raised more than two-thirds of its total funding this year with today’s series E following the close of a $167 million series D round in January.

Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear.

Alcon AG plans to acquire Ivantis Inc. for $475 million at closing, regaining a significant position in the lucrative minimally invasive glaucoma surgery (MIGS) space through the addition of the Hydrus microstent device to its ophthalmology portfolio. In addition to the up-front payment, the deal includes additional unspecified contingent payments dependent on achievement of certain milestones. The transaction is expected to close in the first quarter of 2022.

It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?