FDA

FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic

2019-06-07T11:35:41-04:00

The Medical Futurist | June 6, 2019 Mental health algorithms mimicking empathy? A.I. outsmarting human doctors? Simple big data analytical software presented with clever marketing tactics? It’s difficult to assess the actual state of play when it comes to artificial intelligence in healthcare. Moreover, there’s no database that contains all [...]

FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic2019-06-07T11:35:41-04:00

Roche, J&J Regulatory Leads Weigh In On Pre-Cert’s Progress, Challenges of Regulating Digital Health

2019-06-09T19:06:04-04:00

By Dave Muoio, MobiHealth News | June 4, 2019 At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address. Since it was first announced, [...]

Roche, J&J Regulatory Leads Weigh In On Pre-Cert’s Progress, Challenges of Regulating Digital Health2019-06-09T19:06:04-04:00

FDA Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program

2019-05-26T18:02:38-04:00

By Dave Muoio, MobiHealth News | May 22, 2019 Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification. The FDA has put out a call for new companies to test drive the current framework of its Digital [...]

FDA Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program2019-05-26T18:02:38-04:00

FDA Cracks Down on DIY mHealth Platforms for Diabetes Care Management

2019-05-21T13:21:17-04:00

By Eric Wicklund, mHealth Intelligence | May 20, 2019 The US Food and Drug Administration has issued a warning that jury-rigged, altered or unauthorized mHealth platforms for diabetes care management could cause harm, even death. The US Food and Drug Administration is cracking down on do-it-yourself mHealth devices for people [...]

FDA Cracks Down on DIY mHealth Platforms for Diabetes Care Management2019-05-21T13:21:17-04:00

Insights from the FDA’s Digital Health Lead Bakul Patel at MedCity INVEST

2019-04-29T02:19:55-04:00

By Kevin Truong, MedCity News | April 24, 2019 At the MedCity INVEST Conference in Chicago, the FDA's Bakul Patel spoke about the recent developments in the agency's thinking about regulating the emerging Software as a Medical Device space. The emergence of new data sources and the ubiquity of cloud [...]

Insights from the FDA’s Digital Health Lead Bakul Patel at MedCity INVEST2019-04-29T02:19:55-04:00

FDA Lays Out Plans for a New Review Framework for AI and Machine Learning-based Devices

2019-04-15T12:58:44-04:00

By Conor Hale, FierceBiotech | April 3, 2019 The FDA has begun to reconsider how it reviews and approves medical devices that employ artificial intelligence and to learn from data to adapt their care. The agency hopes a tailored regulatory framework will help promote the development of machine-learning devices and [...]

FDA Lays Out Plans for a New Review Framework for AI and Machine Learning-based Devices2019-04-15T12:58:44-04:00

FDA Regulations Could Create Digital Health Opportunities for Pharma

2019-03-31T07:33:10-04:00

By Laura Lovett, MobiHealth News | March 28, 2019 A new report from PwC predicts that new and proposed FDA regulations could open up doors for pharmaceutical companies looking to develop digital tools. Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. [...]

FDA Regulations Could Create Digital Health Opportunities for Pharma2019-03-31T07:33:10-04:00

FDA Issues Clinical Trials Guidance for Industry – and Upbraiding from Gottlieb

2019-03-18T08:07:51-04:00

By Alaric Dearment, MedCity News | March 15, 2019 The guidance concerned strategies for developing precision medicines and more efficient clinical trial oversight. But the outgoing commissioner criticized drugmakers and CROs' reluctance to change their ways. Following a raft of new proposals designed to expand eligibility for cancer clinical trials, [...]

FDA Issues Clinical Trials Guidance for Industry – and Upbraiding from Gottlieb2019-03-18T08:07:51-04:00

FDA Commissioner Scott Gottlieb to Step Down

2019-03-10T14:11:35-04:00

By Mike Miliard, Healthcare IT News | March 05, 2019 At the Food and Drug Administration, the physician and venture investor promoted policies focused on innovating approaches to population health, opioids, chronic disease, AI and precision medicine. Food and Drug Commissioner Dr. Scott Gottlieb announced his resignation from the FDA [...]

FDA Commissioner Scott Gottlieb to Step Down2019-03-10T14:11:35-04:00

FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products

2019-02-08T10:38:02-04:00

By Dave Muoio, MobiHealth News | February 6, 2019 Released yesterday, the document outlines FDA's preference toward single applications for combination products. The FDA released new draft guidance yesterday regarding premarket review for combination products — those with a mix of components that span across the agency’s drug, biologic and device product categories. [...]

FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products2019-02-08T10:38:02-04:00