In part 2 of our Q&A, Okamura addresses the need for biopharma companies to leverage digital technologies in disease management.

The post Astellas Pharma CEO Q&a (Part 2): We Have To Have Alternatives for Prescription Medicine Business appeared first on MedCity News.

Scott Davis is the CEO of Ekso Bionics, an innovative medical device company making wearable exoskeletons for use in construction but perhaps, more importantly, to help people contending with spinal cord injury.

The post MedCity Pivot: A Conversation About Wearable Robots with Scott Davis appeared first on MedCity News.

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.

The post With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge? appeared first on MedCity News.

The next wave of Medtech innovation must deliver truly smart connected care—not only building on our progress in collecting and integrating information about a patient, such as vital signs, diagnostic results and health history—but also using software to prioritize this information, streamline care delivery and provide actionable insights.

The post Technology Contributes to Clinician Burnout. Here’s How It Can Make It Better. appeared first on MedCity News.

The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.

The post Invitae’s First of Its Kind Cancer Test Receives FDA Marketing Authorization appeared first on MedCity News.

Allurion Technologies has commercialized a gastric balloon in the form of a pill that patients swallow. But the weight loss platform from the now NYSE-listed company also includes AI-driven software that provides insights about a patient’s progress, technology with the potential for use alongside obesity drugs.

The post Newly Public Allurion Aims to Show How Med Tech Can Complement Obesity Drugs appeared first on MedCity News.

Pear Therapeutics was once regarded as a digital therapeutics pioneer, but its spiral into bankruptcy has the industry searching for the best path forward. While some favor going direct to consumers, others say the solution is in generating more robust clinical trial data to persuade hesitant payers.

The post Rigorous Data Are Key to Convince Payers, Investors in the World of Digital Therapeutics appeared first on MedCity News.

Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.

The post FDA Authorizes Better Therapeutics Mobile App for Treating Type 2 Diabetes appeared first on MedCity News.

Appropriate Medicare reimbursement of high-intensity focused ultrasound for prostate disease is a significant development for the treatment for men 65 years and older today.

The post How Medicare Coverage Diversifies Access to Innovation appeared first on MedCity News.

Finalists for the medical device track include an innovative, waterproof alterative to casts, a device geared to trauma care, an approach to improve early detection of lung cancer, cardiac monitoring medtech, and more. Register for the conference today!

The post Here’s a Preview of the Startups Pitching in the Medical Device Track at MedCity INVEST appeared first on MedCity News.

Pear Therapeutics isn’t meeting the commercialization goals for its prescription digital therapeutics, so it’s now seeking strategic alternatives for the business. Prospective buyers can pick up Pear’s FDA-cleared products for substance use disorder, opioid use disorder, and insomnia.

The post Pear Therapeutics’ Cuts Are Not Enough; ‘Strategic Alternatives’ Among Next Steps appeared first on MedCity News.

Allurion Technologies has developed a gastric balloon that does not require surgery. The merger deal taking Allurion public comes as the company continues global commercialization of its technology.

The post Weight Loss in a Pill Device Firm Allurion Heads to NYSE via SPAC Merger appeared first on MedCity News.

In the runup to INVEST and the startup pitch contest, we highlight trends in investment and innovation across bipharma, diagnostics, medical devices, health tech: payer/provider, and health tech: consumer/employer. The deadline has been extended until February 28 and finalists will be announced March 31. Apply today!

The post Apply to MedCity INVEST Pitch Perfect Where Investment Trends and Innovation Converge appeared first on MedCity News.

With five tracks of startups across healthcare and life sciences, INVEST Pitch Perfect, scheduled for May 22-24 at the Ritz Carlton in Chicago, is MedCity’s largest startup pitch contest of the year. 

The post Time Is Running Out to Apply for MedCity’s Largest Pitch Contest of the Year appeared first on MedCity News.

Executives from Huma, Abbott, Smith & Nephew and AliveCor share how they are using real world evidence collection to support remote patient monitoring, maximize patient engagement and navigate the regulatory landscape.

The post Why Digital Health Collaborations Are the Future of Medtech appeared first on MedCity News.

By making documentation and images easily transferrable immediately after the imaging is performed, clinician workflow can be simplified. With modern point-of-care ultrasound workflows, healthcare providers can easily share patient information and provide optimal care.

The post How better ultrasound workflows can mitigate physician burnout appeared first on MedCity News.

A look at how tapping real world evidence from medical devices and patients could be a game changer, improving patient-clinician communication, supporting earlier interventions and helping patients manage their condition.

The post How medtech can crack the patient engagement conundrum and transform the patient experience appeared first on MedCity News.

The FDA said it will review fewer Covid-19 diagnostics for emergency use authorization. The policy update follows an Office of Inspector General report that found the urgency to increase testing availability led to problems, including the authorization of many low-quality tests.

The post FDA narrows EUAs for Covid-19 tests, steering companies to traditional review pathways appeared first on MedCity News.

For most companies and medtech, in particular, good business practices (GBP) happens on multiple levels. On the micro level, it’s more prescriptive (i.e., regulatory best practices or good manufacturing practices). On the macro level, it’s expressed as a set of ethics and principles that govern a company’s conduct.

The post Weathering the good and the bad: Why good business practices work appeared first on MedCity News.

Engage Venture Partners, a Minneapolis-based venture capital firm, recently launched with a focus on early stage medical tech companies. The firm was established to decrease friction between early stage medical tech companies and their investors by bringing its investments to market via special purpose vehicles (SPVs).

The post Carrot Health founder launches SPV-only health tech VC fund appeared first on MedCity News.

A pediatric health system enlisting mixed reality and 3D printing technology illustrates how clinical collaboration and patient education can improve patient outcomes for complex procedures.

The post Convergence of medtech and health tech: Helping providers plan procedures and easing patient anxiety appeared first on MedCity News.

A veteran of GE Healthcare, Joe Gasque talks about how he's growing the company's niche position in the high-paced aesthetics industry, offering services to surgeons, practitioners, medical device and injectables manufacturers.

The post MedShift CEO shares vision for growth appeared first on MedCity News.

Mike Matson evaluated two earlier negative bits of information along with Thursday’s revenue and earnings-per-share miss to conclude that Medtronic’s stock, which has held up despite recent market swings, needs to be downgraded to a “hold” from a “buy”.

The post Skeptical of future performance, spooked by recent misses, Needham analyst downgrades Medtronic’s stock appeared first on MedCity News.

An infographic illustrates how Medtronic’s AccuRhythm AI suppresses false alerts while maintaining sensitivity.

The post Using AI to reduce false alerts for patients with heart monitoring devices to detect cardiac arrhythmias appeared first on MedCity News.

To get approval for the deal, Medtronic agreed to sell an Intersect subsidiary to soothe the FTC’s concerns.

The post With the FTC’s conditional approval, Medtronic completes its $1.1B acquisition of Intersect ENT appeared first on MedCity News.

The Series D round of funding makes Biofourmis a unicorn valued at $1.3 billion. CEO and founder Kuldeep Singh Rajput said that the new capital will be used to expand his company’s remote-monitoring technologies and continue development of digital therapeutics, both as companions to traditional drugs and as monotherapies.

The post Biofourmis adds $300M to ramp up in virtual care, digital therapy clinical trials appeared first on MedCity News.

A recent webinar sponsored by Formlabs underscored the value of 3D printing from a clinical perspective and offered insight on how commercial and regulatory players are thinking about this space.

The post 3D printers have proved their value to hospitals for limb-saving surgery, Covid-19 supply chain issues, and more appeared first on MedCity News.

The second quarter of 2022 kicked off with a new life sciences company joining the public markets, but not via an IPO or merger. Becton Dickinson on Friday completed the spinoff of its diabetes care business, Embecta, which now trades on the Nasdaq.

The post Becton Dickinson spins off diabetes biz, enabling Embecta to embark on its own appeared first on MedCity News.

Formlabs is sponsoring a webinar exploring 3D printing from clinical, commercial, and regulatory perspectives.

The post 3D Printed medical devices for precision surgery appeared first on MedCity News.

Bausch + Lomb is returning to the public markets in an IPO expected to rank among the biggest in healthcare. Speaking at the annual J.P. Morgan Healthcare Conference, Bausch Health Companies CEO Joe Papa discussed the plans to spin off both the iconic eye products business as well as the skin products business, leaving three independent and publicly traded companies.

The post Bausch + Lomb’s IPO plans come into focus as BHC prepares to split into three appeared first on MedCity News.