Braincool AB has scored a breakthrough device designation from the U.S. FDA for its Cooral system, a medical cooling technology for therapeutic hypothermia and oncology. The status acknowledges Cooral’s potential to prevent oral mucositis (OM), a complication of chemotherapy.

The U.S. FDA has granted breakthrough device designation to Cerus Endovascular Ltd. for its Contour neurovascular system for the treatment of intracranial aneurysms. The company is targeting the second or third quarter of this year for the start of its IDE clinical trial.

As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their ability to detect the novel coronavirus is thought to be relatively low, companies that make COVID-19 tests are moving quickly to enhance and revalidate their products.

Patient-centered predictive health company Sema4 said Wednesday it has inked a merger agreement with CM Life Sciences, a special purpose acquisition company led by Casdin Capital and Corvex Management. Upon closing, CM Life Sciences will be renamed and its common stock listed on the Nasdaq global market under a name and ticker symbol yet to be announced.

Theator Ltd., the artificial intelligence (AI)-powered surgical intelligence platform, has raised $15.5 million in a series A financing led by Insight Partners. The funds will be used to scale commercial operations and partnerships with U.S. providers, grow the company’s R&D team and secure its footprint in the field of AI-driven surgical planning, intraoperative support, and review. New investor Blumberg Capital also participated in the round, along with all existing investors including Nfx, Stageone Ventures, Kdt Ventures and Iangels.

Zimmer Biomet Holdings Inc. continued its transformation, disclosing Friday that it will spin off its spine and dental businesses into a separate, publicly traded company. The move will enable the independent company, identified as Newco, to pursue strategies and growth in spine and dental solutions that have not been a major focus for Zimmer Biomet, while allowing the latter to focus on high-growth orthopedic segments.

Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of $153 million. Friday’s Wall Street debut was a show of confidence, upsized from an original plan to offer 7.8 million shares at $15 to $17. The Emeryville, Calif.-based company has granted the underwriters a 30-day option to acquire up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

Becton, Dickinson and Co. (BD) reported revenue of $4.32 billion for the first quarter of fiscal year 2021, up 25.8% on a reported basis and 24.3% on a currency neutral basis. COVID-19 testing contributed 20.5% of that growth, totaling $867 million for the period, including $688 million in Veritor Plus system sales.