Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.

KARACHI, Pakistan – Pakistan is running short of women doctors. That's not due to a lack of medical education facilities – 70% of all medical students are women – but because many of them leave midway through their careers. The Muslim-majority country now is looking to new medical technologies and telemedicine to address this issue. One startup that launched in 2017, Sehat Kahani, is relying on telemedicine to expand the reach of health care by, in large part, tapping into this pool of medical talent.

Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.

PARIS – Six months after floating on the Euronext stock exchange in Paris, Predilife SA from Villejuif, France, is launching the Mammorisk predictive test for breast cancer risk in Europe and the U.S. "Mammorisk is the first multi-criteria test to use data mining, allowing it to combine medical imaging, genetic profile and family history," Pierre Verdet, assistant managing director of Predilife, told BioWorld MedTech.

TEL AVIV, Israel – The use of digital technologies in medical technology is rapidly moving well beyond efforts to organize data or communicate long distance. Multiple companies are now working to use digital technologies to address medical conditions and improve therapeutic outcomes. While some of these companies are technology companies that have taken something of a back door into health care through consumer products (like the Iwatch or Fitbit that can be used to track metabolic activity or by providing technology platforms like Amazon or Microsoft), other entrants are health care companies first that use digital technology to meet health care goals.

TEL AVIV, Israel – Generating all kinds of data that can feed artificial intelligence (AI) and machine learning engines is increasingly cheap and, in many ways, easy but interpreting all that data and translating it into information that is useful to users that range from drug developers to patients remains a significant challenge. Addressing this challenge has blurred the boundaries between traditional technology companies and medical technology companies and forced a rethinking of how treatments are provided, and drugs are developed. And the challenge also creates opportunities for companies that can address this gap.

Philadelphia-based Healthverity Inc. reported it closed a $25 million series C investment round led by existing investor Foresite Capital. Other major investors included Flare Capital Partners and Greycroft. The new investments bring Healthverity's total venture capital funding to $42.3 million and will be used to further develop the company's health care data platform and expand its marketing.

NEW ORLEANS – The Apple Heart study has accumulated data from more than 400,000 participants in its evaluation of the ability of an algorithm to detect abnormalities that may be indicative of atrial fibrillation (AF), although the enrollment came up short of the target of half a million users. Nonetheless, Mintu Turakhia, a cardiologist at Stanford, Calif.-based Stanford University, said that while the study has some significant limitations, "we now have a footprint for evaluating technology such as this, and how to do this in an appropriate and scalable way."

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.

The draft Medicare physician fee schedule (MPFS) is always an event for makers of drugs and devices, and this year is no exception. This time, the draft proposes non-controversially to formalize the specialty practice of heart failure and transplant cardiology, a move that was anticipated. While telehealth would enjoy a renewal of momentum under the terms of the draft, novel oncology drugs would be reimbursed at the wholesale acquisition cost plus 1.35 percent, a considerable shave from the current standard of WAC+6.