Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter.
After winning a brutal proxy battle led by activist investor Carl Icahn, Francis deSouza suddenly resigned as CEO and as a member of the board of Illumina Inc. over the weekend. The company appointed General Counsel Charles Dadswell to serve as the interim CEO while it evaluates internal and external candidates for the position. DeSouza will continue in an advisory role until July 31.
Merit Medical Systems Inc. is making progress on its acquisition badge, with a $100 million purchase of assets from Angiodynamics Inc. following shortly on the heels of its acquisition of a catheter system from Bluegrass Vascular Technologies Inc. for $32.5 million. The acquisitions strengthen Merit’s position in the specialty dialysis devices market and are expected to boost the company’s revenues $13 million to $15 million through Dec. 31, 2023, and by $30 million on an annualized basis going forward.
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
Conformal Medical Inc. plugged the gap in funding needed to complete enrollment in the pivotal CONFORM trial for its left atrial appendage occlusion (LAAO) technology with completion of an oversubscribed $35 million series D fundraising round. The Conformal left atrial appendage seal (CLAAS) system is designed to close off the left atrial appendage in individuals with non-valvular atrial fibrillation to cut the risk of stroke and avoid the use of anticoagulants.
Breakthroughs in early detection of cancer offer increasing hope for better outcomes and longer lives for individuals affected by malignancies. This year’s American Society of Clinical Oncology annual meeting highlighted strong results from several companies at the forefront of this potential transformation.
In the flurry of presentations on early detection of cancer at the 2023 American Society of Clinical Oncology Annual Meeting, Grail LLC stood out for the number of sessions and the strength of its results. In a real-world study presented, Grail’s Galleri multi-cancer early detection (MCED) test cancer signal origin (CSO) demonstrated accuracy of 91%.
The 2023 American Society for Clinical Oncology Annual Meeting featured several notable developments on the diagnostics side, including significant advances in multi-cancer early detection (MCED). Grail Inc. presented its results from SYMPLIFY, the first major study of its MCED test in symptomatic patients. The test showed a negative predictive value of more than 97% and a positive predictive value that exceeded 75% in individuals who presented to primary care with non-specific symptoms that prompted a referral for cancer evaluation.
Royal Philips NV and Masimo Corp. received U.S. FDA clearance that allows the activation of Sedline brain function monitoring, regional oximetry and carbon dioxide measurements in Philips Intellivue MX750 and MX850 patient monitors, which will streamline decision-making for clinicians by eliminating the need for separate pieces of monitoring equipment. The integrated equipment can help clinicians more quickly assess and monitor cerebral oxygenation, anesthetic sedation and patient respiratory performance using the same monitor.
Wesper Inc., a longitudinal and wireless clinical-grade sleep testing platform, showed ‘exceptional accuracy’ in a head-to-head comparison with polysomnography in a study published in The Journal of Clinical Sleep Medicine. The wireless, longitudinal sleep testing platform had a breathtaking 95% correlation with the cumbersome gold standard test for sleep apnea.
