INTRODUCTION

The medical technology industry is constantly evolving and improving, with new devices and technologies being developed all the time. While these advances have the potential to greatly improve patient care and outcomes, it is important to ensure that these devices are safe and effective before they are made available to the public. So, here is a recap of the key FDA approvals in December 2022.

1. BIOCORP’s Mallya Devices Receives FDA 510(k) Clearance

By obtaining a 510(k) approval, BIOCORP will be able to expedite the submission of Mallya's future generations in the diabetes field and in other therapeutic areas where the company has partnered with others.

The Mallya medical device is a smart sensor that is directly attached to insulin pen injectors, making them connected devices. Mallya automatically collects and records key treatment information (selected insulin units, date, and time of injection) and transmits it to a dedicated digital application.

Eric Dessertenne, CEO of BIOCORP, said, "This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process. This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP's ability to meet the highest regulatory requirements.”

2. IRRAS Receives US FDA 510(k) Clearance For Its Next Generation IRRAflow Control Unit

IRRAS received US FDA 510(k) clearance for its class II next-generation IRRAflow control unit that enhances the procedural workflow for health care professionals treating critically ill patients suffering from intracranial bleeds.

"IRRAS prides itself on consistently upgrading its products to better meet the needs of its customers, and the US regulatory clearance of the next generation IRRAflow control unit is the latest example of our team delivering upon that promise," said Will Martin, President and Chief Executive Officer of IRRAS. "Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimize care for their critically ill patients. Being able to introduce the latest IRRAflow functionality is the exciting next step toward accomplishing our mission to becoming a global leader in the neurocritical space."

3. Click Achieves FDA Breakthrough Designation For Prescription Digital Migraine Therapy

The FDA granted the designation to Click’s CT-132 as an adjunctive preventive treatment for episodic migraine in adults, given that many patients have difficulty accessing specialty care or experience incomplete remission. The designation should help expedite the development and review of Click’s device.

Click is saying little about the migraine product, only revealing that the candidate “combines multiple clinically-validated mechanisms of action” with its platform “to reduce the number of migraines per month in patients with four or more migraine days per month.”

“Breakthrough further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation and neurobehavioral interventions. Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine,” said Dr. Shaheen Lakhan, chief medical officer of Click.

4. Ultromics Receives FDA Clearance For AI Diagnostic Heart Failure

Ultromics' EchoGo Heart Failure, an AI solution for echocardiography uses AI to accurately detect HFpEF from a single echocardiogram image, which accounts for 50% of the 64 million cases of heart failure worldwide and has overtaken heart failure with reduced ejection fraction (HFrEF) as the most prevalent form of the deadly disease.

Dr Ross Upton, CEO and founder of Ultromics, said, "We are delighted that the FDA has recognised EchoGo Heart Failure as a breakthrough device and has cleared the technology to provide reliable detection of HFpEF. The technology improves the accuracy of HFpEF detection, enabling more patients to receive treatment which will reduce the significant burden on patients and healthcare systems alike.”

"Although compelling progress has been made in the diagnosis and treatment of many forms of heart disease, heart failure hospitalisations and mortality continue to rise globally. It is now time to make a change. Together with our FNIH AMP HF partners, we aim to redefine the heart failure care pathway and improve world-wide patient outcomes."