Digital Health

Tidepool CEO talks Pre-Cert era, interoperability

Amazon and Pixar software veteran Howard Look spoke to MedTech Dive about working through FDA's software development evaluation pilot and the implications of an insulin dosing app that works with many brands' devices.
By Maria Rachal • UPDATED: Aug. 16, 2019 at 12:01 p.m.
Healthcare AI funding hits new high as sector matures

Startups in the sector raised $864 million across 75 venture capital-backed deals and financing during the second quarter, beating the previous quarterly high by about $100 million.
By Nick Paul Taylor • Aug. 07, 2019
CMS pilot to give doctors patient Medicare claims data

CMS hopes to eventually roll out the initiative to all Medicare fee-for-service providers, giving doctors Medicare claims data for their patients, including prescribed medications, procedures, diagnoses and other providers.
By David Lim • July 30, 2019
Walgreens adds Dexcom, Propeller to digital marketplace

The collaborations are an expansion into chronic care management with connected devices for patients with diabetes, asthma and chronic obstructive pulmonary disease.
By Susan Kelly • July 24, 2019
Medtronic to distribute AI stroke detection and triage software

The technology comes from Google Ventures-backed artificial intelligence startup Viz.ai, which won a De Novo clearance last year for its clinical decision support software aimed at speeding identification of large vessel occlusions.
By Maria Rachal • July 22, 2019
Pear files insomnia and depression software as Pre-Cert pilot 510(k)

CEO Corey McCann told MedTech Dive he hopes the digital therapeutic will be cleared in the first half of 2020, but cautioned Pear has "a good deal of learning to do in terms of the FDA response to this specific submission."
By David Lim • July 19, 2019
Fertility apps hold promise, but less precise than conventional methods, study finds

A Nature journal analysis of data captured by the Kindara and Sympto apps led independent researchers to predict self-tracked results will support the quantification of infertility or daily pregnancy chances.
By Nick Paul Taylor • July 19, 2019
Fitch Solutions tips Roche to challenge Philips for digital pathology market

After enjoying a brief monopoly, Philips faces a clutch of competitors planning regulatory filings.
By Nick Paul Taylor • July 10, 2019
Insulin pen smart cap maker in talks to supply Sanofi

French medical device maker Biocorp's Internet-connected cap is designed to work with a conventional insulin pen and can automatically transmit dosage data to a smartphone app.
By Susan Kelly • July 08, 2019
As digital health investing matures, report says sector dodges a bubble

Venture fund and research firm Rock Health said the pace of investment dollars flowing into the sector may top 2018’s record funding as a digital health IPO drought appears on the verge of ending.
By Susan Kelly • July 02, 2019
Health tech IPO activity picks up with filings from Livongo, Health Catalyst, Phreesia

With its revenue more than doubling between 2017 and 2018, chronic disease management startup Livongo may break the drought of digital health IPOs.
By Maria Rachal • June 28, 2019
FDA warns hackers could interfere with Medtronic pump insulin dosing

The weakness may affect pumps used by 4,000 patients in the U.S. and cannot be fixed with a software patch.
By Nick Paul Taylor • June 28, 2019
Livongo adds compatibility with Apple Watch, Fitbit, other smartwatches

The chronic disease management startup said it hopes step data will inform notifications aimed at spurring healthy habits.
By David Lim • June 26, 2019
Smartphone heart data mirrors gold standard EKG in study

UCSF researchers said it was the largest analysis of real-world heart rate data remotely obtained and stratified by demographics and medical conditions.
By Nick Paul Taylor • June 26, 2019
Mount Sinai joins LabCorp to adopt Philips' digital pathology

The clinical lab giant will integrate the system into Mount Sinai’s eight hospitals, enabling remote review of images and surgical slides.
By Nick Paul Taylor • June 19, 2019
FDA 'white hat' hacking tools may combat medical misinformation

Cybersecurity techniques the agency uses to protect medical devices could also help fight the spread of medical misinformation, former FDA Commissioner Robert Califf wrote in a journal.
By Susan Kelly • June 17, 2019
Margin for error 'almost zero' in testing pediatric devices

As barriers dog pediatric device development, one FDA-backed group is trying a different path.
By Maria Rachal • June 14, 2019
AMA adopts measures to shape development, uptake of AI systems in healthcare

The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.
By Nick Paul Taylor • June 13, 2019
China leads world in digital health adoption, Philips survey finds

Healthcare professionals in China are more likely to recommend patients use digital health technologies than their peers in the West.
By Nick Paul Taylor • June 12, 2019
Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA

Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.
By Nick Paul Taylor • June 11, 2019
Abbott and Tandem in the spotlight at diabetes meeting

Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.
By Nick Paul Taylor • June 07, 2019
Consumers favor mobile health when paired with office visits

Three-quarters of patients surveyed by SOTI said mobile products improve convenience, though popularity and use of different types of services varied.
By Tony Abraham • June 06, 2019
Executives expect AI to transform healthcare within 3 years

Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.
By Nick Paul Taylor • June 06, 2019
Apple Watch, mesh slings among new NESTcc projects

The real-world evidence hub selected 12 new test cases to evaluate its model in medical device regulatory and clinical decision-making.
By Susan Kelly • June 05, 2019
Muscle relaxation app helps calm migraine in small NYU study

Migraine sufferers who used the smartphone app at least twice a week had four fewer headache days per month on average.
By Susan Kelly • June 05, 2019