Elidah Inc. expanded its line of U.S. FDA-cleared, over-the-counter devices to reduce or eliminate urinary incontinence in women with the launch of Elitone Urge for urge incontinence. The device is a muscle stimulator that can be worn under clothes as the user goes about her day and rebuilds muscle tone.
The Feinstein Institutes for Medical Research, the research arm of Northwell Health, landed a $3.4 million grant from the Wellcome Trust to evaluate the use of transcranial magnetic stimulation (rTMS) for schizophrenia. Feinstein will undertake a five-year, double-blind, randomized trial to see whether rTMS improves cognitive or other symptoms of schizophrenia. The technology currently has FDA approval for use in individuals with depression and obsessive-compulsive disorder.
Dexcom Inc. posted a 19% increase in first quarter revenues compared to 2022 boosted by a stunning 27% organic growth in sales outside the U.S. With clearance of the G7 device in hand, another record set in new patient starts and coverage of continuous glucose monitoring (CGM) systems by CMS effective this month, the year is shaping up to be quite rosy for the diabetes device company.
Quest Diagnostics Inc. evidently found what it was looking for, as it agreed to acquire Haystack Oncology Inc. in an all-cash deal valued at up to $450 million with $300 million at closing and $150 million contingent on meeting specific milestones. Haystack focuses on minimal residual disease (MRD) testing, which can detect residual or recurring cancer in its early stages and help guide therapy decisions using blood samples rather than biopsied tissue. The companies expect the transaction to close before the end of June.
The 10-year update to Medtronic plc’s ENGAGE registry for its Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated high degrees of protection from aneurysm and sac regression in a real-world setting. The results were presented at the 2023 Charing Cross Symposium in London on April 26.
Insulet Corp. has taken the lead in the race to bring insulin delivery systems to individuals with type 2 diabetes with U.S. FDA clearance of its Omnipod Go device. The delivery system is adapted for use by adults who use once-a-day basal insulin. The company plans to roll out Go in 2024.
Two tough years have taken a toll on Medtronic plc with a warning letter for its diabetes unit, a reorganization that will spin off its respiratory, patient care and renal groups and layoffs of an undisclosed number of employees that began last week. The announcement late Friday of the U.S. FDA approval of the Minimed 780G insulin pump system could be a turning point for the company that brings it back into the competition for the growing diabetes market.
Establishment Labs Holdings Inc. presented remarkably positive results at three years for its Motiva silicone breast implant at The Aesthetic Meeting 2023 in Miami on April 20. In keeping with the two-year results previously presented, the data demonstrated very low rates of device failure or contracture, which have plagued other implants. The strength of the investigational device exemption study makes an approval from the U.S. FDA ever more likely.
Alphatec Holdings Inc. (ATEC) acquired the robotic-enabled minimally invasive (REMI) system from Fusion Robotics LLC, a division of Integrity Implants Inc. (dba Accelus Inc.), for $55 million in cash. The deal brings a sophisticated navigation system for spine procedures into the Alphatec fold, something management previously identified as a target for expansion. Alphatec focuses on spinal surgery solutions. REMI integrates navigation and robotics into a range of spinal procedures and allows use of either a 3D imaging scan or 2D fluoroscopic images to precisely guide instruments and implants to the desired location during surgery.
Compared to recent fundraising rounds in the med-tech space, Noah Medical Inc. was veritably deluged with cash in its series B. Softbank Vision Fund and Prosperity7 Ventures led the round, which rained down $150 million on the medical robotics company. Other participants included Hillhouse, Sequoia China, Shangbay Capital, Uphonest Capital, Sunmed Capital, Lyfe Capital, 1955 Capital, AME Cloud Ventures and undisclosed strategic investors.