The FDA cleared Hyperfine Research Inc.’s advanced image reconstruction technology using deep learning for its portable magnetic resonance imaging device, Swoop. The bedside MRI unit’s artificial intelligence application received clearance in January and is used with deep learning to improve image quality and diagnostic value. Hyperfine and Liminal Sciences Inc., which share a founder in serial entrepreneur Jonathan Rothberg, are both combining with special purpose acquisition company Healthcor Catalio Acquisition Corp. to go public in a deal valued at $580 million. The companies reported on Nov. 29 that the Securities and Exchange Commission declared the registration statement on form S-4 for the combination to be effective and the SPAC’s shareholders will vote on the transaction on Dec. 21.

Sword Health Technologies Inc. slipped another $189 million into its coffers with an oversubscribed $163 million series D fundraising round that spilled into an additional $26 million secondary transaction. The enthusiasm for the round points to the keen interest in digital delivery of musculoskeletal (MSK) physical therapy, which has driven Sword and competitor Hinge Health Inc. both into rarified unicorn territory with valuations of $2 billion and $6.2 billion, respectively.

The FDA gave Pear Therapeutics Inc. a second breakthrough device designation with the company’s Reset-A prescription digital therapeutic (PDT) for alcohol use disorder getting the regulatory agency’s speed pass. The news comes a week out from the vote of stockholders of blank-check company Thimble Point Acquisition Corp. Inc. on a combination with Pear that will take the digital therapeutic company public.

Stryker Corp.’s analyst day provided comfort to those concerned about the company’s ability to return to its strong pre-pandemic revenue and earnings growth after its lower than expected third-quarter earnings results. Management offered positive reports of fourth-quarter trends and a long-term strategy unfolding according to plan.

Sense Biodetection Ltd. closed a $65 million series B investment round on a high note with an additional $15 million pouring in from previous investors. The Abingdon, England-based company raised $50 million in a first tranche of the round in April. Koch Disruptive Technologies LLC, a subsidiary of Koch Industries Inc., led both parts of the round.

Aquyre Biosciences Inc., formerly known as Lltech, raised $19,945,534 in a series A2 preferred stock financing round to fund commercialization of its Celtivity system for on-site adequacy assessments of tissue biopsies. Ceros Financial Services acted as placement agent for more than $17.14 million of the funds raised in this round as part of its recently announced commitment to raise $100 million in the next 12 months for investment in early-stage medical technology and medical device companies.

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.