With an eye toward helping women approaching menopause and their providers make decisions regarding care, the FDA has allowed the marketing of the PicoAMH Elisa diagnostic test, which measures the amount of anti-Müllerian hormone (AMH) in the blood. The test, from Webster, Texas-based Ansh Labs LLC, aims to help determine whether a woman is approaching menopause or is likely to have had her final menstrual period. To arrive at its favorable decision, the agency examined data for the PicoAMH Elisa test through de novo premarket review, a regulatory pathway for low-to-moderate risk devices of a new type.

CLEVELAND – Every year at the Cleveland Clinic Medical Innovation Summit, a highly anticipated event is the unveiling of the Top 10 list of the technologies that will come to the market and change patient care. This year was no different, with pharmacogenomic testing, which uses a patient's genetic makeup to predict an individual's metabolism of drugs, topping the list, with an eye toward combating the opioid crisis.

CLEVELAND – Every year at the Cleveland Clinic Medical Innovation Summit, a highly anticipated event is the unveiling of the Top 10 list of the technologies that will come to the market and change patient care. This year was no different, with pharmacogenomic testing, which uses a patient's genetic makeup to predict an individual's metabolism of drugs, topping the list, with an eye toward combating the opioid crisis.

CLEVELAND – How are telemedicine and wearable technologies changing health care and how physicians see patients? That question was the focus of a panel that examined how such emerging technology can play a role in improving primary care. The panel took place during the Cleveland Clinic's 2018 Medical Innovation Summit and was part of the a series of discussions on how technologies, including digital health, are disrupting health care.

CLEVELAND - How are telemedicine and wearable technologies changing health care and how physicians see patients? That question was the focus of a panel that examined how such emerging technology can play a role in improving primary care. The panel took place during the Cleveland Clinic's 2018 Medical Innovation Summit and was part of the a series of discussions on how technologies, including digital health, are disrupting health care.

CLEVELAND – Incentivizing innovation and advancing collaboration took center stage in Cleveland this week, with one panel discussing how artificial intelligence (AI) and ongoing concerns about dealing with government entities will affect the development of new technologies and patient care.

Austin, Texas-based Luminex Corp. has agreed to acquire Milliporesigma's flow cytometry portfolio for $75 million, consisting of about $69.9 million to be paid under a stock and asset purchase agreement and roughly $5.1 million in committed inventory purchases.

Apple Inc. has extended its reach again. This time, the tech giant and Zimmer Biomet Holdings Inc. have teamed up on a new app for the Apple Watch intended to connect patients undergoing knee and hip replacements with their surgical care teams. In the wake of this development, Zimmer Biomet, of Warsaw, Ind., this week reported the kickoff of the Mymobility clinical study, designed to assess the app's impact on outcomes and overall costs for joint replacement patients.