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Anumana wins FDA clearance for ECG-AI algorithm

Screen shot of sample data from Anumana’s ECG-AI LEF. [Image courtesy of Anumana]Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.

Cambridge, Massachusetts-based Anumana, an Nference portfolio company, worked in collaboration with Mayo Clinic. They designed the breakthrough medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The company’s pulmonary hypertension (PH) early detection algorithm also won FDA breakthrough device designation last year.

Developed as software-as-a-medical device (SaMD), the algorithm screens LEF in adults at risk for heart failure. It uses data from a routine 12-lead electrocardiogram (ECG). Anumana developed it using research from Mayo Clinic that included more than 100,000 ECG and echocardiogram data pairs. The data came from more than 25 studies evaluating more than 40,000 patients in the U.S. and abroad.

Further data from 16,0…

Fast Five: Cordis acquires MedAlliance for more than $1B, SmileDirectClub files Chapter 11

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 3, 2023.

Fast Five by MassDevice · Cordis acquires MedAlliance for more than $1B, SmileDirectClub files Chapter 11

The FDA this week approved Enable Injections’ wearable injector. Fast Five hosts Sean Whooley and Danielle Kirsh share what the wearable injector does and what executives are saying about the approval. Read more here>>

Boston Scientific announced the launch of its next-generation insertable cardiac monitor. Find out what this next-gen system does, who some of the key players in the ICM space are and more in today’s episode. Read more here>>

Pulse Biosciences and CardioNXT are partnering up to initiate a pulsed-field ablation trial. Whooley details what the goal of the collaboration is and how the two companies plan to ach…

Report: Private equity firm in negotiations for Medtronic business units

Medtronic (NYSE: MDT) + and private equity firm Carlyle Group reportedly entered negotiations over two units the medtech giant put on the spinoff block.

Nearly a year ago, Medtronic announced its intention to pursue a separation of its Patient Monitoring and Respiratory Interventions businesses. Both are part of the company’s Medical Surgical portfolio. Months later, reports surfaced citing Siemens Healthineers and GE HealthCare among those interested in the units. Later reports suggested ICU Medical joined the running as well.

However, Reuters reports that the company may go outside of medtech to sell its businesses. The outlet says Carlyle entered into exclusive negotiations for a majority stake in the units, valued at more than $7 billion. Reuters cited “people familiar with the matter.”

The report says, if a deal goes through, the units would move to a new company majority-owned by Carlyle. Medtr…

Pulse Biosciences, CardioNXT to collab on pulsed-field ablation trial

[Image courtesy of Pulse Biosciences/CardioNXT]Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a collaboration with CardioNXT to support its AFib treatment.

The collaboration supports Pulse Biosciences’ planned first-in-human study of its pulsed-field ablation technology. Hayward, California-based Pulse develops a proprietary nanosecond pulsed-field ablation (nsPFA) cardiac catheter to treat AFib.

Pulse and CardioNXT plan for their partnership to integrate the nsPFA catheter and the CardioNXT iMap navigation and mapping system. This enables electrophysiologists to successfully visualize individual cardiac structures when using the integrated platforms. They can then place the catheter for circumferential ablations of targeted pulmonary veins in AFib treatment.

CardioNXT CEO Jerome Edwards said in a news release that Pulse’s nsPFA technology provides “a highly differentiated” solution. He said integrating systems …

Boston Scientific launches next-gen insertable cardiac monitor

The LUX-Dx II+ insertable cardiac monitor. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that it launched its next-generation LUX-Dx II+ insertable cardiac monitor (ICM) system.

The system offers long-term monitoring for arrhythmias associated with conditions such as AFib, cryptogenic stroke and syncope.

Insertable cardiac monitors are a competitive space. Abbott won FDA clearance in May for its Assert-IQ ICM, while Medtronic continues to release positive data around its Linq monitors.

Boston Scientific designed LUX-Dx II+ with dual-stage algorithms to detect and verify potential arrhythmias before alerting clinicians. This provides actionable data for clinical decision-making when the clinicians receive an eventual alert.

LUX-Dx II+ also features remote programming capabilities. These allow physicians and care teams to adjust event detection settings and record symptom…

Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B

MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion.

The companies initially announced the planned deal in October of last year.

Cordis, which develops interventional cardiovascular and endovascular technologies, made a $35 million investment last year. Its upfront closing payment totals $200 million, with achievement milestones reaching up to $125 million. With up to $775 million available in commercial milestones through 2029, the total consideration comes to $1.135 billion.

MedAlliance develops the Selution SLR sustained sirolimus drug-eluting balloon program. The company said its product family complements Cordis’ existing product portfolio along with its sales, marketing and distribution expertise.

Selution SLR provides a controlled sustained drug release, similar to a drug-eluting stent. It features unique micro-reservoirs made of biodegradable polymer intermixed with siro…

FDA approves wearable injector from Enable Injections

The Empaveli Injector. [Image courtesy of Enable Injections/Apellis Pharma]Enable Injections announced today that it received FDA approval for its enFuse injector for the delivery of Empaveli.

Empaveli, commercialized by Apellis Pharmaceuticals, treats adults with paroxysmal nocturnal hemoglobinuria (PNH). The injector — in this case, called the Empaveli Injector — offers self-administration of the pharmaceutical. The compact, wearable device streamlines the self-administration experience with minimal disruption to daily lives.

Get the full story at our sister site, Drug Delivery Business News.

SmileDirectClub files for Chapter 11, plans recapitalization process

SmileDirectClub (Nasdaq:SDC) announced that it initiated a process to implement a recapitalization transaction.

The move includes voluntarily filing for protection under Chapter 11 of the U.S. Bankruptcy Code. Nashville, Tennessee-based SmileDirectClub filed in the U.S. Bankruptcy Court for the Southern District of Texas.

SmileDirectClub says it intends for the recapitalization to bolster its balance sheet and fuel growth initiatives. With additional capital and a stronger financial position gained, the company expects the move to help it “thrive as an international oral care leader for many years to come.”

The company’s founders committed to invest at least $20 million to bolster its balance sheet and protect its financial health. SmileDirectClub expects to have up to $60 million in additional capital available upon the satisfaction of certain conditions.

During the restructuring process, the company expects to provide its denta…

Benchmarks, Pitfalls, and Proactive Considerations for Exceptional DFM in Precision Metal Components

Design for manufacturability (DFM) is a critical aspect of precision metal components, as it directly impacts the quality, cost, and efficiency of the manufacturing process. We’re discussing four important benchmarks for exceptional DFM in precision metal forming, listing the biggest pitfalls to avoid, followed with proactive tips for DFM success.

Four Important Benchmarks for Exceptional DFM in Precision Metal Forming

Material Selection: Choose the right material for the application. Consider factors such as material properties (e.g., strength, ductility, formability, corrosion resistance), cost, and availability. Selecting the appropriate material can significantly impact the final product’s performance.

Tolerances and Dimensional Control: Define precise dimensional tolerances and specifications. Ensure that the design allows for the required tolerances without compromising the functionality of the part. Achieving tighter tolerances will often require…

How medtech could be affected by a U.S. government shutdown

[Image from Unsplash]The FDA is expected to continue much of its operations if the U.S. government shuts down this weekend, while CMS and the NIH face some government shutdown uncertainties.

The critical deadline for lawmakers in the U.S. to extend federal funding is rapidly approaching, and House Republicans have yet to reach an agreement over passing a bipartisan deal that would prevent a government shutdown. The shutdown would affect Americans’ lives in many ways, including the closure of national parks, museum closures, airport delays, federally-funded infrastructure work and more. However, essential services would continue, and that includes most operations at the FDA.

Presently, the FDA has carryover user fee funding that allows for the agency to continue operations of certain activities, including the regulation of human and animal drugs, biosimilar biological products and medical devices.

Medical device user fees support the review and approva…

SeaStar wins FDA breakthrough nod for selective cytopheretic device

The Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical (Nasdaq:ICU) announced today that the FDA granted breakthrough device designation for its selective cytopheretic device (SCD).

Denver-based SeaStar designed the SCD for use in patients in the intensive care unit (ICU) with acute or chronic systolic heart failure. These patients have worsening renal function due to cardiorenal syndrome or right ventricular dysfunction. They’re awaiting the implantation of a left ventricular assist device (LVAD).

SeaStar’s SCD halts the downward spiral perpetuated by a hyperinflammatory state, SeaStar chief medical officer Dr. Kevin Chung says.

The company said it expects the breakthrough nod to expedite the clinical development and regulatory review of the SCD.

SeaStar submitted a first-in-human study that saw a patient with severe chronic heart failure treated with the SCD. That patient was ineligible for heart tran…

Ypsomed has a new CFO, board member

Samuel Künzli

Ypsomed announced today that it selected Samuel Künzli to take over the company’s chief financial officer (CFO) position.

Niklaus Ramseier elected to hand over the reins to the CFO position after more than 20 years in the post. The transition begins on March 31, 2024, with Ramseier remaining available to the drug delivery device maker for strategic projects. Künzli begins as CFO on April 1, 2024.

Get the full story at our sister site, Drug Delivery Business News.