Shacey Petrovic is stepping down as president and CEO of Insulet. Jim Hollingshead, who currently serves as president of the sleep and respiratory care business at ResMed, will replace Petrovic on June 1. "We believe CEO Petrovic was well-respected, having led a period of strong growth and business transformation at [Insulet]," said Marie Thibault, a medtech analyst at BTIG.
Johnson & Johnson's Ethicon business won FDA clearance for the Monarch platform (through the Auris Health subsidiary) to be used in endourological procedures. The news should bring some much-needed attention to J&J's surgical robotics program. The regulatory milestone makes Monarch the only multispecialty, flexible robotic solution for use in both bronchoscopy and urology, the company noted.
Abbott’s latest FDA clearance will enable the company to detect four common sexually transmitted infections with the Alinity m assay. The assay is a multiplex test that Abbott says will help address increasing rates of sexually transmitted infections. The pandemic has contributed to a decline in routine screening and an increase in cases, the company noted.
And in case you missed our last Medtech in a Minute report...
Medtronic is recalling delivery catheters used with the Harmony transcatheter pulmonary valve (TPV) system. The company said the bond holding the capsule at the end of the delivery catheter can potentially break during a procedure to place the TPV. When this happens, it can cause procedure delays or require the patient to undergo additional surgeries. Also, a capsule bond break while in use during a procedure could cause serious harm to the patient. FDA said there have been six reported complaints about this issue, including one injury. No deaths have been reported in association with this device. Medtronic has reported several device recalls this year. Seperately, the company is also investigating changes to prevent communication problems between Medtronic's Percept PC implantable neurostimulator and the clinician/patient programmer systems. The company has received six confirmed reports of the issue, including five in the United States and one in Switzerland.
Hologic continues to be impacted by the global chip shortage on the breast health imaging side of its business, but strong COVID-19 testing sales helped overcome those challenges in the company's fiscal second quarter. CFO Karleen Oberton said significant uncertainties still exist in the chip market and it is possible that the company will face an additional $50 million headwind in the back half of 2022. Last quarter, Hologic said it expected $200 million of revenue would be pushed out of fiscal year 2022 because of the chip shortage.
After seeing an increase in volume procedures during the first quarter, Boston Scientific raised its outlook for the full year. The company now expects to see sales growth between 7% and 9% in 2022.