The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs.

LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks.

LONDON – Quanta Dialysis Technologies Ltd. has raised £38 million (US$46.7 million) in the first close of a series C round, to fund a U.S. FDA 510(k) submission and U.K. commercial launch of its SC+ home hemodialysis system. With the cash now in hand, both these events are due to occur before the end of 2019. "We've got a lot of work to do," said John Milad, CEO of Quanta. "This is the rocket fuel."

PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.

Two pieces of legislation of interest to the med-tech industry are making the rounds in Washington. One would require that online sales of contact lenses be accompanied only by a prescription, and the other would bolster telehealth services for methamphetamine addiction in rural areas, where the narcotic's epidemic has taken much of its toll. The bills arrive as other developments suggest an improved environment for contact lenses and telemedicine, auguring a better market for both in the months and years ahead.

HONG KONG – Olive Healthcare Inc., a South Korean biotech startup, said its abdominal fat scanner Bello has received an FDA approval to sell the device in the U.S. The company said it plans to launch the scanner in the country this December, after a market test. The miniature device is portable with a weight of 3.8 oz (107 g), measuring 3.9 inches (10 centimeters) long, 3.1 inches wide and 1.9 inches high.

It has been a few years since there was an active market for digital health IPOs. But that's changed now. Chronic health care management company Livongo Health Inc. has raised $355 million in an IPO, following last month's $609 million public debut for health care workflow management software company Change Healthcare Inc.

Deep learning algorithms developed at the Memorial Sloan Kettering Cancer Center (MSK) were able to distinguish prostate, skin and breast cancer with nearly perfect accuracy in a recent clinical trial. The technology has already been licensed exclusively by New York-based startup Paige.AI, which snapped up a $25 million series A early last year to continue to advance it.

With the ongoing push toward value-based care, providers are looking for ways to improve patient outcomes while also lowering health care costs. Los Angeles-based Dearhealth Inc.'s artificial intelligence-powered software-as-a-service (SaaS) platform aims to do meet that demand by helping physicians better manage patients with chronic conditions. Now Philips Health Technology Ventures and other large investors are putting their money behind the company, seeing an opportunity to generate real movement in advance population health.

Getting on top of the persistent HIV epidemic requires getting ahead of new cases, but only about 7% of at-risk patients have been advised of a prophylactic drug regime approved by the FDA seven years ago. Two new studies appearing in The Lancet HIV suggest that an algorithm that uses electronic health record (EHR) data can help physicians identify their at-risk patients who are good candidates for pre-exposure prophylaxis (PrEP), thus improving the odds that modern medicine might finally put an end to the scourge of acquired immunodeficiency syndrome.