Second Sight Gives Clearer Picture of Strategy Going Forward
Second Sight Medical Products provided an update on its strategic options and gave some clarity on a plan going forward.
The Sylmar, CA-based company noted its situation was fluid and would explore options that include securing additional funding and exploring business alternatives that may include partnering, acquiring, investing in, or combining with businesses that may or may not be in a related industry.
In a press release, the visual prosthesis firm’s acting CEO Matthew Pfeffer noted the company had been able to attract interest from third parties. Â
“Since taking over a...
Source: MDDI - April 28, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Implants Source Type: news
Is Medtech Prepared for Recovery?
While certain medical devices, supplies, and diagnostics necessary for treating COVID-19 patients have seen increased demand during the pandemic, the postponement of non-emergency procedures has impacted demand for many other products.
Orthopedic procedures have been the most obvious type of postponement, noted Brian Chapman, managing partner and leader of the medical technology industry vertical at ZS Associates. “These are not necessarily elective,†he told MD+DI. However, “the thought process is that maybe they would be safer in two months. You don’...
Source: MDDI - April 28, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news
Drug-Delivery Patch Shows Promise for an Overlooked Disease
A biodegradable drug-delivery patch met the primary and multiple secondary endpoints in a phase 2b study in patients with oral lichen planus (OLP), a chronic inflammatory condition characterized by lesions and ulcers inside the mouth.
According to AFYX Therapeutics, the study is the largest randomized, double-blind, placebo-controlled study ever conducted in OLP patients. The 20 μg dose Rivelin clobetasol patch (Rivelin-CLO) demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of four weeks, the Copenhagen, Denmark-based ...
Source: MDDI - April 28, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: R & D Source Type: news
Volunteer Efforts Vet N95 Cleaning Methods
As the severity of the COVID-19 pandemic began making itself apparent to the healthcare industry, sterilization expert Amit Gupta began getting phone calls from concerned clinician friends.
“I have a number of friends who are doctors who work in hospitals,†Gupta, the director of engineering at Billerica, MA-based Consolidated Sterilizer Systems, said. “And, as mask supply started entering the forefront of thoughts of healthcare workers, some of my friends started reaching out to me, asking if they could sterilize the masks.
“I started researching it a...
Source: MDDI - April 27, 2020 Category: Medical Devices Authors: Greg Goth Tags: Sterilization COVID-19 Source Type: news
Alphatec Pulls Out of Deal to Acquire EOS Imaging
Alphatec is pulling out of its agreement to acquire EOS Imaging because of negative impacts on the market caused by the novel coronavirus [COVID-19].
Carlsbad, CA-based Alphatec said based upon its assessment, it concluded that a “Material Adverse Effect†has occurred, resulting in circumstances that are no longer conducive to the completion of the transaction described in the terms of agreement. Instead, Alphatec said the door is open for the two companies to collaborate.
The surgical spine specialist announced in late February that it would pick up EOS Imaging for $88 million, plus deb...
Source: MDDI - April 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Orthopedics Source Type: news
CareDx Brings Home-Based Monitoring to Transplant Patients
In the age of COVID-19 and social-distancing, diagnostic companies have to provide more than just assays. CareDx has tapped into this idea and launched a solution that will enable remote home-based monitoring of transplant patients.
The South San Francisco, CA-based company said its RemoTraC can help reduce visits to busy labs and hospitals and that immunosuppressed transplant patients at the highest risk during the COVID-19 pandemic can limit their potential exposure.
Typically, transplant patients require frequent blood tests which normally require in-person visits to draw sites at labs or hospitals.
“B...
Source: MDDI - April 27, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Implants Source Type: news
Edwards Lifesciences Drops 2020 Revenue Guidance Due to COVID-19
While Edwards Lifesciences reported first-quarter sales growth of 14%, the structural heart company saw a steep drop in procedure volume in the last few weeks of the quarter due to COVID-19.
"As you might expect, procedure volumes in March varied greatly by geography, even by hospital, as patients and providers turned their focus to the pandemic," CEO Mike Mussallem said during the company's first-quarter earnings call, according to a SeekingAlpha transcript.
Mussallem said the company expects the impact of COVID-19 on its transcatheter aortic valve replacement (TAVR) sales to be most severe in the second quarter, followed...
Source: MDDI - April 25, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
Medtech in a Minute: COVID-19 Impacts Medtronic, Conformis Ends Furlough, and More
Medtronic Braces for COVID-19 Financial Impact
While certain Medtronic products are in high demand due to COVID-19, an update from the company shows that the vast majority of its businesses have experienced declines during the global pandemic. In the United States, which represented about 53% of Medtronic's total revenue before the crisis, the company began to see an impact to revenue the week of March 16. Over the last few weeks, the company’s U.S. weekly revenue has declined about 60% year-over-year on average, excluding any impact from customer bulk purchases.
Â...
Source: MDDI - April 24, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news
7 Bold Predictions for Medtech After COVID-19
(Source: MDDI)
Source: MDDI - April 24, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Business Source Type: news
How to Select a Medical Device CMO
In conclusion, whether the mission is to change the world or expand production of an established product, a good CMO partner can handle the complexities of mass-scale manufacturing. As with any business relationship, trust is key, and there’s no substitute for medical industry experience and certifications. When a CMO can open doors to integration with multidisciplinary partners, that is icing on the cake. In the end, the OEM-CMO relationship should be one that liberates the device developer to excel at its core competency and take its business to the next level. (Source: MDDI)
Source: MDDI - April 24, 2020 Category: Medical Devices Authors: Claudio Hanna and Jennifer Ponti Tags: Contract Manufacturing Source Type: news
A Self-Driving Shuttle Makes Special Deliveries During COVID-19
Beep, an Orlando, FL-based autonomous shuttle service provider, typically runs its self-driving shuttle on a daily fixed route throughout Lake Nona, FL. With operation temporarily paused due to COVID-19, the company decided to use its shuttle to support the fight against COVID-19.
In March, fully autonomous Beep shuttle buses began transporting COVID-19 tests from a drive-thru testing site to a lab facility on Mayo Clinic's Jacksonville, FL campus without an onboard attendent.Â
The Jacksonville Transportation Authority, Beep, NAVYA (a French company specialized in the design ...
Source: MDDI - April 24, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 IVD Source Type: news
FDA Grants Breakthrough Designation for Heart Failure Device
VisCardia has been granted Breakthrough Device Designation for an implantable technology to treat heart failure (HF).
More specifically, the Portland, OR-based company’s VisOne is a device that treats moderate to severe HF with reduced ejection fraction and preserved ventricular synchrony. The system delivers synchronized diaphragmatic stimulation (SDS) therapy.
Greg Harris, VP of Clinical and Regulatory Affairs spoke with MD+DI about VisOne and how the device has the potential to make a difference in the lives of HF patients.
“Other technologies are usually focused on strengthening the ...
Source: MDDI - April 23, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
Supplier Stories for the Week of April 19
(Source: MDDI)
Source: MDDI - April 23, 2020 Category: Medical Devices Authors: Daphne Allen Tags: Assembly and Automation Source Type: news
Conformis to Bring Furloughed Employees Back to Work
There’s some significant news coming out of Conformis today. The custom orthopedic implant company said it expects most of the 80 employees it had to furlough about a month ago will be returning to active employment as early as April 27, 2020. The company said there some employees who have separated from it in the normal course of business.
The Billerica, MA-based firm said two factors contributed to the furlough ending. The first reason is the $4.7 million loan it received from the Paycheck Protection Program administered by the U.S. Small Business Administration. These loans are offered because of the e...
Source: MDDI - April 23, 2020 Category: Medical Devices Authors: Omar Ford Tags: COVID-19 Orthopedics Source Type: news
Medtronic Braces for COVID-19 Financial Impact
While certain Medtronic products are in high demand due to COVID-19, an update from the company shows that the vast majority of its businesses have experienced declines during the global pandemic.
Medtronic said it expects COVID-19 to negatively affect its fiscal fourth quarter financial results, which ends Friday. Given the progression of COVID-19 around the world and the timing of the company’s fiscal quarter, Medtronic’s fourth quarter includes an additional month of impact compared to companies that operate on a calendar-based fiscal year.
Like many of its peers, includin...
Source: MDDI - April 23, 2020 Category: Medical Devices Authors: Amanda Pedersen Tags: COVID-19 Business Source Type: news
