Cala Health Archives - Medical Design Sourcing

Cala Health has positive essential tremor treatment data

The kIQ device. [Image from Cala’s website]Cala today announced results from multiple studies supporting positive outcomes for patients using its TAPS therapy for essential tremor (ET).

San Mateo, California-based Cala develops multiple devices for treating essential tremor, including the Cala Trio and the kIQ. The company launched the kIQ wrist-worn device last year. They deliver transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor.

One randomized, pragmatic CVS Health trial found that adding Cala TAPS therapy to standard of care improved outcomes over standard of care alone. The study recruited patients from the database of health insurer AETNA. The company says it marks the largest prospective device study run in essential tremor to date, with 310 subjects.

According to a news release, the study found significant improvements in tremor power and Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores ove…

These 11 medical device inventions are the best of 2023, Time magazine says

Time’s best medical device inventions of 2023 include: (clockwise from top left) ViviStim, Coros, Cala kIQ, InVision. [Images courtesy of the companies]

Time magazine recently named 11 medical device inventions among its best inventions of 2023.

The devices highlighted in the ranking ranged from wearables to treat tremor to leadless pacemakers.

Time magazine says it has identified the most impactful ideas, devices and technologies around the world for more than 20 years. The publication says it compiled the list through nominations from its editors and global correspondents, with special attention to certain categories like medical innovations, accessibility, AR/VR, sustainability, wellness and more.

Time then graded each nominee based on a number of key factors that included originality, efficacy, ambition and impact.

This year’s list included 11 devices from startups and major…

Cala launches next-gen wearable for essential tremor, Parkinson’s therapy

The Cala kIQ wearable. [Image from Cala’s website]Cala announced today that it launched its next-generation Cala kIQ system, a wearable device that delivers therapy for neurological disorders.

The San Mateo, California-based company develops the Cala Trio device for transcutaneous afferent patterned stimulation (TAPS) therapy. Cala designed the Trio device for treating tremor. Its kIQ system delivers therapy for action hand termor relief in those with essential tremor and Parkinson’s disease.

Cala kIQ also delivers TAPS therapy, validated by large clinical studies and real-world evidence. It enables on-demand, comfortable, at-home therapy for ease of use and management of action hand tremors. This type of tremor occurs when a patient undergoes intentional movement or posture, Cala said.

“At Cala, we’ve always been committed to expanding patient access and accelerating innovation in TAPS therapy for indications beyond essential tremor,” said Rene…

Cala Health, Cue Health have layoffs in California

[Image courtesy of Nastuh Abootalebi on Unsplash]Cala Health and Cue Health (Nasdaq:HLTH) both recently filed with the state of California to confirm reductions in their workforces.

The two companies are the latest to join the long list of medtech companies cutting employees amid a challenging time for the industry. To date, MassDevice has reported on more than 18,000 medtech employees who have been let go.

According to California WARN notices, Cala, a neuromodulation technology developer, laid off 107 employees.

The filing lists the type of reduction as a permanent layoff pertaining to Cala’s San Mateo, California location. California received the notice of the workforce reduction on May 17. According to the filing, the layoffs go into effect on June 30.

Cala develops transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor. The company delivers TAPS therapy with its Cala Trio device. Last month, Cala introduced its nex…

And the best medical device innovation of 2022 goes to…

The Cala Health Cala Trio [Image courtesy of Cala Health]

The Galien Foundation last night honored Cala Health’s Cala Trio essential tremor treatment wearable as 2022’s best medical device innovation.

The foundation describes its Prix Galien awards as the global equivalent of the Nobel Prize for the life science industry.

The Cala Trio offers a non-invasive method to send signals to the brain to treat essential tremor rather than deep-brain stimulation. It was one of two dozen devices that were nominees in this year’s competition. (Here is Medical Design & Outsourcing‘s roundup of the full 24.)

More about Cala Health and its Cala Trio

MDO recently interviewed Cala Health co-founder and Chief Scientific Officer Kate Rosenbluth and CEO Renee Ryan about the creation of the technology. The Cala Trio has FDA clearance as an external upper limb tremor stimulator, available by…

October 2022 Issue: Women in Medtech

Rachel Ellingson is driving Zimmer Biomet toward new tech

What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic

How Medline maintains quality while innovating and growing

How a wrist-worn device treats essential tremor

Diversity in medtech: 2022 markedly the best for women in medtech

Diverse executive teams bring more innovation to medtech Diversifying the executive suite is more than just a push for representation — it helps bring more diverse ideas to the table to innovate for more than half of the global population.

The leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing.

Women hold just 23% of executive roles at the top 100 medical device companies, up 2 percentage points since 2021. After Accuray and Ambu appointed f…

How a wrist-worn device treats essential tremors

Cala Health co-founder and Chief Scientific Officer Kate Rosenbluth [Photo courtesy of Cala Health]

Cala Health co-founder Kate Rosenbluth developed a solution for essential tremors, a debilitating disorder that can make it difficult to perform daily tasks like drinking from a glass or writing checks.

A neuroscientist and engineer by training, Cala Health co-founder and Chief Scientific Officer Kate Rosenbluth saw the necessity for an easy treatment option for essential tremors while doing her biodesign fellowship at Stanford University.

She was performing observations at Stanford Hospital and clinics for several months, following neurosurgeons, neurologists, practitioners and any nurse that was willing to allow her to observe unmet needs in medicine. That’s when she noticed an opportunity to help patients in the field of essential tremor and hand tremor.

Essential tremor is a nervous system d…

Real-world evidence supports Cala’s essential tremor treatment

Cala announced today that real-world evidence validates its transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor.

San Mateo, California-based Cala delivers TAPS therapy with its Cala Trio device. It designed the treatment to reduce tremor in those living with essential tremor (ET).

Data from the study validates TAPS in effectively reducing tremor, Cala said. The therapy did so with no loss of effect over time while improving patient quality of life, according to a news release.

Cala shared the data from a retrospective post-market surveillance study. “Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor” evaluated the real-world effectiveness of Cala TAPS therapy. It evaluated 321 users who completed at least 90 days of therapy and met the criteria for analysis. The study took place between August 2019 through June 2021.

In the study, TAPS reduced tremor power by 71%, confirming prev…

The 24 best medical device innovations of 2022

The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards.

There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021.

The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

Nominees need to be FDA-approved for the market within the last five years and show major potential to affect healthcare. The winners will be announced in October at the Prix Galien USA Awards in New York City.

This year, the foundation nominated 24 medical device innovations, 22 biotechnology products and 33 pharmaceutical agents. The devices range from an intraocular lens to a bariatric stapler.

“Every year, evaluating and recognizing the amazing submissions that come through for the Prix Galien Awards is one of the greatest honors,” said Dr. Sue Des…

Cala Health announces new chief commercial, financial officers amid leadership expansion

Cala Health announced today that it expanded its leadership team with a number of appointments, including new chief commercial and financial officers.

New executives joining the company — which develops bioelectronic medicines to provide new therapies for chronic diseases — hold experience from major players in the medtech space, including iRhythm, Johnson & Johnson, Boston Scientific, Medtronic, Google and more.

The company also announced a new, larger headquarters in San Mateo, California. Cala designed the larger, LEED-certified building to support its growth as a flexible workspace with a high-functioning manufacturing and fulfillment center.

Joining Cala as chief commercial officer (CCO) is Doug Biehn, who most recently served as EVP of marketing at iRhythm. He was also COO at AliveCor and chief marketing officer at Blue Shield of California.

“I’m excited to be part of such an innovative and patient-centric company that is freeing people …

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news releas…