Dublin-based Medtronic plc has filed a PMA supplement with the U.S. FDA for its next-generation, implantable sacral neuromodulation (SNM) device, Interstim Micro, and for its Interstim Surescan MRI leads. Interstim Micro is intended to help patients with overactive bladder (OAB), urinary urge incontinence, unobstructed urinary retention and fecal incontinence (FI).

Roughly 10% of newborns require some form of assistance at birth, and 1% need major resuscitative efforts. The time to help one of these babies can be measured in minutes, so having the right specialist on hand can have a huge impact on the child's outcome. Six-and-a-half years ago, the Mayo Clinic launched the Newborn Resuscitation Telemedicine Program (NRTP) to offer telemedicine consults to community hospitals within its health system during high-risk neonatal resuscitations. The program has been successful in reducing unnecessary transfers and growing the number of patient referrals to Mayo Clinic.

The FDA has granted 510(k) clearance to the first hernia mesh featuring a nanometer-level surface texture, enabling better post-implant tissue ingrowth and reducing the incidence of adverse reactions. The Exogenesis Hernia Mesh, by Billerica, Mass.-based Exogenesis Corp., is indicated for the repair of abdominal wall hernias and deficiencies that require reinforcement to stabilize the condition and achieve a positive surgical outcome. The company expects to launch the product nationwide in 2020.

Edmonton, Alberta-based startup Tevosol Inc. is hoping to make its mark in the growing warm perfusion organ transport market with a portable system for lungs that leverages a unique negative pressure ventilation technology. The company recently raised CAD$2 million (US$1.5 million) in seed financing to advance its Ex-Vivo Organ Support System (EVOSS) and is seeking a lead investor for a series A round to further product development and support clinical trials.

Lisle, Ill.-based Endotronix Inc. scooped up $70 million in an expanded series D funding round led by Life Science Partners. The funds will support the company's PROACTIVE-HF IDE clinical trial of the Cordella Pulmonary Artery Sensor System and further commercialization of the Cordella Heart Failure (HF) System.

BOSTON – The shift to value-based care models and rise in digital technologies is causing medical device companies to rethink how and where they invest in innovation. There's less emphasis on core and adjacent product investments and more focus on transformational advances that don't just add new bells and whistles but expand access, improve outcomes and lower costs. Just what that looks like and how companies are adapting to this new innovation landscape was the focus of a session at the Medtech Conference this week.