iRhythm receives FDA clearance for ZEUS System for Zio watch
iRhythm Technologies, a leading digital healthcare solutions firm focused on advancing cardiac care, announced that it received FDA 510(k) clearance for the ZEUS (Zio ECG Utilization Software) System for the Zio Watch. It is produced in partnership with Verily, which is an Alphabet precision health company; the ZEUS System combines deep learning algorithms with a proven and well-established cardiac arrhythmia service. The ZEUS System is the AI algorithm and solution component of the Zio Watch, which is:
- A sensor-based wearable for non-invasive,
- Clinical grade, and
- helps in long-term continuous monitoring for atrial fibrillation
Verily received FDA 510(k) clearance for the Zio Watch. The Zio Watch integrated with the ZEUS System is a unified, prescription-based solution that addresses clinician workflows, care pathways, and the patient experience. The cleared Zio Watch is a wearable solution that not only detects atrial fibrillation but also characterizes the amount of atrial fibrillation over time, thus aiding a clinician in diagnosis. The Zio Watch uses continuous photoplethysmography and an artificial intelligence-based algorithm used to detect atrial fibrillation and calculate its burden estimate. A preliminary report is then shared with the patient’s clinician for review, potentially leading to a diagnosis and clinical intervention afterward.
iRhythm has what is believed to be the world’s largest repository of labeled ECG data, which it leveraged to develop its proprietary PPG algorithm.
The Zio Watch will complement Zio monitors by adding a modality with longer wear times for patients requiring long-term monitoring to detect, characterize and manage atrial fibrillation. The Zio Watch is a cost-effective, non-invasive monitoring solution and will fully integrate with the Zio service. iRhythm is planning to introduce the ZEUS System for a limited market evaluation in 2023.
Respiri Introduces the Wheezo Device and App to the US Market
Respiri, an Australian digital health company, has made Michigan Children’s Hospital the first US customer for its wheezo device app and healthcare monitoring platform. The Software as a Service (SaaS) platform detects wheeze, a common sign of asthma, chronic obstructive pulmonary disease, and other respiratory diseases, and provides an objective assessment of airway blockage. The wheezo system, which was approved by the FDA last year, has now been connected with Access Telehealth’s remote patient monitoring platform Remotli at Michigan, and the first US patients are anticipated to utilize it in the coming weeks.
The system will be reimbursable and will target children with asthma to reduce exacerbations and hospitalizations, improve patient outcomes, and save healthcare costs. Access is currently collaborating on integration with Michigan’s electronic medical record (EMR) system. According to the company, monitoring and maintaining abnormal breathing patterns in respiratory disease patients is currently insufficient in the United States.
Patients use wheezo to record 30 seconds of normal breathing with the device placed on the trachea, which Respiri claims are sufficient to offer an objective assessment of wheeze that can assist diagnose diseases and guide treatment. The mobile app aids patients in controlling their asthma by tracking symptoms, triggers, medication use, and environmental factors such as pollen and pollution levels.
As per the DelveInsight analysis in the “Chronic Obstructive Pulmonary Disease Treatment Devices Market Report,” the global chronic obstructive pulmonary disease (COPD) treatment devices market is expected to increase at a CAGR of 6.37% during the forecasted period (2022-2027). The rise in demand for chronic obstructive pulmonary disease treatment devices is mostly due to increased exposure to air pollution, airborne particles, chemicals & fumes, secondhand smoke, industrial chemicals, and dust, all of which contribute to the global rise in COPD prevalence.
CONMED to Acquire Medical Device Start-up Biorez for USD 85 Million
The CONMED company on Monday announced a definitive agreement to acquire privately held Biorez, Inc. (Biorez) for USD 85 million in cash at closing, subject to adjustment, and up to an additional USD 165 million in growth-based earnout payments over a four-year period. The company’s existing credit facility will most likely finance the acquisition, and the deal is expected to be completed in early August 2022.
Biorez is a New Haven, Connecticut-based medical device start-up focused on advancing soft tissue healing with its proprietary BioBrace® Implant technology. The BioBrace implant is a novel bioinductive scaffold designed to fortify soft tissue where it is weak and facilitate healing. The FDA has approved BioBrace® in a variety of product sizes.
“The addition of Biorez and its BioBrace® platform represents an important step forward for our sports medicine portfolio,” commented Curt R. Hartman, CONMED’s Chair of the Board, President, and Chief Executive Officer. “BioBrace® fits seamlessly into our existing suite of products, and we are excited to advance the next generation of healing in sports medicine. BioBrace® represents the type of high-growth, high-margin platform that drives our long-term vision for CONMED.”
Kevin Rocco, Chief Executive Officer of Biorez, added, “I am proud of the Biorez team for developing an innovative healing solution that provides a new treatment option for surgeons and patients. We are thrilled to join CONMED to accelerate the growth of our technology on a global scale.”
CONMED anticipated that this transaction would bring about USD 1 million to its recently disclosed full-year 2022 revenue estimate. CONMED expected that the purchase will be dilutive to adjusted cash earnings per share by USD 0.10 to USD 0.15 in 2022 and 2023 but accretive afterward. As a result, CONMED now anticipates full-year 2022 adjusted diluted net profits per share in the USD 3.25 to USD 3.45 range.
Ambu Announces FDA Clearance of Fifth-Generation Single-Use Bronchoscope
In the latest regulatory updates in the MedTech market, the Columbia-based medical device maker, Ambu Inc., has announced that it has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for its bronchoscope, Ambu® aScopeTM 5 Broncho. It is a single-use sterile bronchoscope.
Earlier, in May 2022, Ambu announced clearance from the European regulatory authority for its bronchoscopes. With the approval from US and EU authorities, Ambu is now looking forward to the commercialization of the aScope 5 Broncho and the full high definition Ambu® aBoxTM 2 processing unit in Europe and the USA. The aScope 5 Broncho family has advanced imaging and design features. It is equipped with a new high-resolution camera chip, which, in combination with the aBox 2, delivers a superior image.
Bronchoscopy is a considerably complex medical procedure requiring high-performance image quality and handling scopes. Bronchoscope Market is a competitive domain with several prominent MedTech companies operating in the segment. With the clearance for its aScope 5 Broncho, Ambu now leads the entry of single-use endoscopes in the bronchoscopy suite.
As per DelvInsight’s latest assessment report on the “Global Bronchoscopes Market,” some of the key factors such as growing prevalence of respiratory diseases such as tuberculosis, the rising prevalence of lung cancers, the growth in the number of cases related to chronic obstructive pulmonary diseases, and increasing product development activities in the domain, will significantly drive the market growth in the coming years. Furthermore, the Bronchoscopes Market is expected to grow at a CAGR of 7.46% during the forecast period (2022 to 2027) and is expected to reach USD 29.38 billion by 2027.
Glaukos Announces FDA 510(k) Clearance of iStent infinite®
The ophthalmic medical technology and pharmaceutical company – Glaukos Corporation pivots around novel therapies for glaucoma treatment, as well as corneal disorders and retinal diseases treatment. It announced that it got 510(k) clearance from the U.S. FDA for their novel iStent infinite® Trabecular Micro-Bypass System in a standalone procedure for elevated intraocular pressure (IOP) reduction in patients with primary open-angle glaucoma uncontrolled by prior medical and surgical therapy.
The iStent infinite contains three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of up to approximately six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. The iStent infinite has a similar mechanism of action to the company’s two-stent iStent inject® W Trabecular Micro-Bypass System, which is approved by the FDA for the reduction of IOP in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.
“This FDA clearance for iStent infinite represents a significant milestone for Glaukos and the MIGS market as the first FDA-cleared micro-invasive implantable device indicated for use as a standalone treatment option for glaucoma patients not undergoing concomitant cataract surgery,” said Thomas Burns, chairman and chief executive officer. “Supported by strong pivotal data highlighting favorable safety and effectiveness, we believe iStent infinite provides ophthalmic surgeons a compelling new interventional glaucoma alternative designed to provide foundational, 24/7 IOP control for their patients in need. We are grateful to the clinical investigators and patients who participated in the clinical trial for their instrumental roles in helping us reach this pioneering achievement and bring iStent infinite to the U.S.”