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 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.

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.

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.

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

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.

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!

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.

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.

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!

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. 

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.

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.

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 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.

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.

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).

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.

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.

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”.

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

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

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.

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 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.

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

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.

We are building upon the foundation of digital laparoscopy and adding machine vision, augmented intelligence, and deep learning capabilities.

In order to benefit from the Virtual1Care trend, pharma and medtech companies must ensure that their digital health tools, wrapped around a drug or device, comply with evolving regulations.

The company would become part of GE’s ultrasound business, expanding its capabilities to include surgical visualization. GE plans to spin out its healthcare division into a publicly traded company in 2023.