The U.S. CMS posted the draft Medicare physician fee schedule (MPFS) for calendar year 2023, and advocates of telehealth will be cheered by a proposed extension of some pandemic-driven telehealth services throughout 2023. The draft is less generous in connection with external electrocardiogram patches in a move that could ding Irhythm Technologies Inc., and its Zio XT device, but analysts at BTIG predict that any hit to reimbursement rates is likely to be offset with greater sales volumes, leaving Irhythm and its investors in a solid place going forward.

The COVID-19 pandemic shone a bright light on the need for and utility of telehealth, which in turn prompted the U.S. Centers for Medicare & Medicaid Services (CMS) to temporarily expand telehealth coverage. Some of those coverage policies are set to expire when the public health emergency ends, and a group of stakeholders, including the American College of Cardiology, are urging Congress to pass legislation that would make some of these benefits permanent, a potential boon for many telehealth entities.

With a new CEO at the helm, remote patient monitoring (RPM) company Qardio Inc. believes 2022 can be a pivotal year to drive adoption of its 4G and Bluetooth-enabled cardiac solutions. The San Francisco-based company recently launched Qardiocore, an ambulatory ECG, and Qardiodirect, an end-to-end remote patient monitoring and telehealth service.

Vicentra BV has closed a $74 million series C financing round to accelerate the European rollout of its wearable insulin patch. The small, lightweight system Kaleido is the company’s flagship product and consists of two pumps controlled by a Bluetooth wireless connected handset. The small size rests on a pumping action that – unlike a conventional syringe mechanism – uses micro-pulse technology to deliver accurate and consistent doses of insulin.

Israeli startup Ophthalmic Sciences Ltd. is targeting 2023 for regulatory clearance of its artificial intelligence (AI)-based contactless intraocular pressure (IOP) measuring device, IO Perfect. The technology, which combines AI visual analysis in a virtual reality headset, enables remote monitoring of glaucoma. The device is designed to be used at home, in eye clinics, emergency room departments, pharmacies and primary physician settings.

Sword Health Technologies Inc. slipped another $189 million into its coffers with an oversubscribed $163 million series D fundraising round that spilled into an additional $26 million secondary transaction. The enthusiasm for the round points to the keen interest in digital delivery of musculoskeletal (MSK) physical therapy, which has driven Sword and competitor Hinge Health Inc. both into rarified unicorn territory with valuations of $2 billion and $6.2 billion, respectively.

The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed.

Alivecor Inc. is partnering with blockchain technology company Solve.Care to connect users of its Kardiamobile device to physicians through a telehealth network. Tallinn, Estonia-based Solve.Care’s blockchain platform, the Global Telehealth Exchange (GTHE), is an open global cross-border telehealth network currently available in 27 countries. Alivecor’s Kardiamobile 6L device is the first and only six-lead personal ECG cleared by the FDA. Through the partnership, Kardiamobile devices will be integrated with GTHE where physicians will be able to access a user’s electrocardiogram (ECG) reading upon their consent through teleconsultations.

The Ernst & Young Pulse of the Industry 2021 report outlined several ways med-tech companies can benefit from fundamental changes in business wrought by the pandemic to build a stronger foundation for the future. While the need for more agile supply chains and the drive to measure social and environmental impact as well as financial metrics have affected all economic sectors, COVID-19 transformed the med-tech industry in specific ways that could have long-lasting impact.

Software-as-a-medical device (SaMD) came into its own during the pandemic as digital health applications enabled patients to receive care from home through telemedicine, apps and remote patient monitoring. At the 2021 Medtech Conference, a panel of regulators, advocates and digital health executives discussed how the last 18 months may permanently change the regulation of these devices, the steps manufacturers can take to secure the footholds they gained, and how the U.S. CMS can enable digital health to achieve its promise.