Digital Health
Payers' and patients' growing preference for outpatient care is increasing pressure on private providers to continually reassess how they deliver value. Jean-Philippe Grosmaitre and Guillaume Duparc, partners at L.E.K. Consulting, outlined growth opportunities available to private hospitals.
As brain-computer interfaces near US approval, neuroethics and neural data privacy move center stage. Major medtech deals reshape the market, while new FDA digital health leadership and updated AI, wellness and CDS guidances signal a more flexible regulatory approach.
As biopharma continues to push the boundaries of innovation, the most powerful breakthroughs are coming from the discovery of new drug modalities, the reinvention of old ones and a strategic application of multi-modality treatment regimens.
Device-based neurotherapeutics face a coverage gap that drug developers do not, and as the field moves toward combination approaches, that asymmetry could undermine important innovation.
Device-based neurotherapeutics face a coverage gap that drug developers do not, and as the field moves toward combination approaches, that asymmetry could undermine important innovation.
“We believe, ultimately, with a personally formulated product, which actually there is, I don't want to say zero competition, but very small competition for, we want to own that category,” says CEO Stephan Gratziani.
Germany’s updated digital healthcare “manifesto” document reflects the need to dovetail with EU’s EHDS and factor in advances in AI, and provide for a new system of primary care. The medtech industry calls for faster assessments of AI-enabled technology and better access to telemonitoring tools.
With EU MDR/IVDR review proposals out, UK MHRA progress on a premarket regulation and, up ahead, a prospective consultation on accepting the CE marking indefinitely, now is a good time to assess EU-UK regulatory positions for the benefit of UK industry, says ABHI director Steve Lee.
FDA updates pair of guidance documents relaxing its posture on how it regulates general wellness devices and clinical support software. Industry mostly welcomes changes, agreeing with agency’s view that lighter regulation will help spur innovation.
Healthtech companies seek to optimize the opportunity of AI while navigating a thicket of requirements from providers as well as regulations like the EU MDR. Andrew Davies, digital health lead at the Association of British HealthTech Industries, explained the importance of streamlining AI processes.
FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.
Hanmi Pharm Group announces new mid-term strategy including expansion of its obesity focus to aging with goal of more than doubling revenue by 2030 and becoming a true global player.