Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.

The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%.

Boston Scientific Corp. grabbed the remaining shares of Devoro Medical Inc. and its Wolf thrombectomy platform in a transaction valued at $269 million. Freemont, Calif.-based Devoro stands to gain an additional $67 million if the company achieves undisclosed clinical and regulatory milestones. Boston Scientific began investing in Devoro in 2019 and currently holds 16% of Devoro. The deal, the Marlborough, Mass.-based company’s fourth major transaction since the start of the second quarter, is expected to close by the end of the year. It follows the acquisitions of Preventice Solutions Inc., of Rochester, Minn., for $1.225 billion in April, which added to the company’s cardiac wearables, and Menlo Park, Calif.-based Farapulse Inc. for $295 million in June, to build out its cardiac ablation position. Boston Scientific purchased Yokneam, Israel-based Lumenis Ltd. for $1.07 billion, in a transaction that just closed three weeks ago.

Prophet, Oncohost Ltd.’s artificial intelligence-driven proteomics profiling platform, predicted response to immune checkpoint inhibitor (ICI) therapy in non-small-cell lung carcinoma (NSCLC) patients in a study presented at the European Society for Medical Oncology Virtual Congress 2021. While ICI can generate a significant positive response in some patients with advanced NSCLC, in others the therapy promotes tumor growth, making identification of likely responders prior to treatment critical.

Sight Sciences Inc. may have visions of a substantial settlement following Ivantis Inc.’s $60 million settlement with Glaukos Corp. this week or the Menlo Park, Calif.-based company may have its sights set on knocking a competitor out of the market entirely. Both are possible outcomes of the suit Sight Sciences announced this morning that alleges infringement of four of its patents by Ivantis for its Hydrus Microstent. Sight Sciences makes the Omni surgical system, which competes with the Hydrus and the Glaukos Istent in the minimally invasive glaucoma surgery (MIGS) space.

Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach.

Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach. The new round pushed total funding for development of the San Francisco-based company’s brain data software platform to $30.1 million.

After three years of litigation and nearly a decade of skirmishes, Ivantis Inc. settled with Glaukos Corp. for $60 million to be paid in two installments, with the first $30 million due by Dec. 31, 2021, and the second $30 million by Dec. 31, 2022. In addition, Irvine, Calif.-based Ivantis will pay Glaukos a 10% royalty through April 26, 2025, on sales of Ivantis’ Hydrus Microstent in the U.S. or international sales supplied out of the U.S. With just two weeks to go until their scheduled court date of Sept. 28, the companies finally saw eye-to-eye, reaching a cross-licensing agreement and hammering out a covenant to refrain from future litigation regarding the technologies involved in the Hydrus or Glaukos’s Istent, both used to treat glaucoma.

Cala Health Inc. is moving quickly to establish leadership in treatment for essential tremor with its recent inclusion in the International Essential Tremor Foundation (IETF) guidelines as the only non-pharmacological, non-surgical treatment recommended and positive treatment results from a real-world study. “We’re very pleased with the validation from IETF and the research presented at MDS that demonstrates the impactful benefit of our therapy for those suffering from essential tremor,” said Kate Rosenbluth, founder and chief science officer of Cala Health.

Zoll Medical Corp.’s plans to wake up the sleep apnea market segment advanced with the acquisition of Itamar Medical Ltd. for $538 million in cash. Itamar focuses on the diagnosis and treatment of sleep apnea, a common and complicating comorbidity of the cardiovascular patients served by Zoll. The deal continues Zoll’s acquisitive trend, following the purchase of Minnetonka, Minn.-based Respicardia Inc., another sleep apnea-focused company, in April and Therox Inc., of Irvine, Calif., in 2019. Zoll has operated as an Asahi Kasei Corp. subsidiary since its own acquisition by the Tokyo-based conglomerate in 2012. Zoll will acquire all outstanding shares of Itamar for $31 per American depository share (ADS) or $1.03 per ordinary share. The deal represents a more than 50% premium over the price of Itamar’s Nasdaq-listed ADS on Sept. 10. Itamar’s shares spiked 43.41% in premarket trading on news of the acquisition.